Research
The identifier a device package has to carry
Medical devices carry a two-part code on the label, one half naming the model and the other naming the batch. The rule behind it also builds a public database, and it says who has to keep that database honest.
Two segments doing two different jobs
The general rule is short. The label of every medical device has to bear a unique device identifier, and every device package has to bear one too.
The identifier has two parts, and the regulation defines each. A device identifier is a mandatory, fixed portion that identifies the specific version or model of a device and the labeler of that device. A production identifier is a conditional, variable portion.
What the production identifier carries depends on what the label already says. It identifies the lot or batch, the serial number, the expiration date, or the date the device was manufactured. For a human cell or tissue product regulated as a device, it carries a distinct identification code required elsewhere in the rules.
The conditional part is the mechanism worth understanding. Wherever a device label includes a lot number, a serial number, a manufacturing date or an expiration date, the identifier has to include a production segment conveying that information.
This is not the drug number. A national drug code is a listing number for a drug under a different part of the rules, and the two identify different kinds of object.
The rules also define who carries the duty. A labeler is any person who causes a label to be applied to a device, intending it to be commercially distributed without further replacement or modification of the label. It also covers a person who causes a label to be replaced or modified with the same intent.
One thing is expressly not a modification. Adding the name and contact information of a person who distributes the device, without any other change to the label, does not make that person a labeler.
The form it takes on the package
The identifier has to be presented in two forms, side by side.
Easily readable plain text is one. Automatic identification and data capture technology is the other. The rules define that as any technology conveying the identifier in a form that can be entered into an electronic patient record or other computer system by an automated process.
Where that technology is not evident on visual examination of the label or package, its presence has to be disclosed on the label or package.
The identifier itself has to be issued under a system operated by the agency or by an accredited issuing agency. It has to conform to three named international standards, and use only characters from the invariant character set of a fourth.
One shortcut exists for the lowest risk class. A class one device bearing a universal product code on its label and device packages is deemed to meet the whole subpart, and that retail code serves as the identifier.
The definitions behind all this are narrower than everyday usage. A device package means a package containing a fixed quantity of a particular version or model. A shipping container, whose contents may vary from one shipment to another, is treated as something else.
Reuse is where the rule has teeth
Three short sections govern what an identifier may and may not be attached to, and together they are what makes it useful.
Only one device identifier from any particular issuance system may be used to identify a particular version or model. A device identifier may be used to identify only one version or model.
Where a version or model is discontinued, its device identifier may not be reassigned to another device. If a discontinued model is reintroduced with no changes that would require a new identifier, the previous one may be used again.
A change forces a new one. Where a change to a device results in a new version or model, a new device identifier has to be assigned to it. Creating a new device package requires a new identifier for that package.
Relabeling is treated the same way. A relabeler assigns a new device identifier and keeps a record showing the relationship of the prior identifier to the new one.
Devices meant to be reused and reprocessed carry the identifier permanently. Take a device that must bear an identifier on its label, is intended to be used more than once, and is reprocessed before each use. It also has to bear a permanent marking of the identifier on the device itself.
The database behind the code
The identifier on the box is a key into a public repository, and the labeler has to fill it in.
Fourteen fields are required for each version or model. The first group identifies the product. The device identifier, the proprietary name as it appears on the label, and any version or model number. The second group is about safety attributes. Whether the device is labeled as sterile, and whether it is labeled as containing natural rubber latex that contacts humans. Also whether a patient may safely be exposed to magnetic resonance imaging while using it or with it implanted. The third group is administrative. The size where more than one exists, and the type of production identifiers on the label. Then the premarket submission number or a statement of exemption, the listing number, a nomenclature term or code, and the total number of individual devices in the package.
Three further fields concern the labeler itself: its name, a telephone number or email address for a designated contact, and the name of each issuing agency whose system it uses.
Each labeler designates an individual as the point of contact with the agency on device identification, and that person is responsible for ensuring the required information is provided. Submissions are electronic unless a waiver has been obtained.
Timing is fixed to the label. The information is submitted no later than the date the label has to bear an identifier. Updates are submitted no later than the date a device is first labeled with the changed information, or within ten business days of the change where the information does not appear on the label.
The database is a closed list rather than an open form. A labeler may not submit information other than what the rules specify, except where the agency acts to permit additional types, which it calls ancillary information. Any change to what may be submitted is announced at least sixty days in advance.
Exceptions, corrections and records
A list of device types is excepted from carrying an identifier on the label, and reading it shows what the system is for.
It includes a device used solely for research, teaching or chemical analysis and not intended for any clinical use. A custom device. An investigational device. A device intended for export. A class one device exempted by regulation from the manufacturing practice requirements. And individual single-use devices distributed together in one package and not intended for individual commercial distribution, an exception that is not available for an implantable device and that does not relieve the package itself.
Where a labeler relies on an exception from permanently marking a reprocessed device, the basis for that decision has to be documented in the design and development files.
The database is not assumed to be correct forever. Where the agency becomes aware that submitted information appears incorrect or potentially misleading, it may notify the labeler. The labeler then has thirty days to provide corrected information, or a satisfactory explanation of why the information is correct.
Records close the loop. A labeler retains, and submits on specific request, records showing all identifiers used for devices required to bear one, and the version or model associated with each. Those records are kept for three years from the date the labeler ceases to market that model.
Key takeaways
- Every medical device label and every device package has to bear a unique device identifier.
- The identifier splits into a fixed segment naming the version, model and labeler, and a conditional segment naming the lot, serial number or dates.
- It appears in two forms, plain text and machine-readable, and the machine-readable form has to be disclosed where it is not visually obvious.
- An identifier may name only one version or model, and a discontinued one may not be reassigned to a different device.
- Fourteen fields per model plus three about the labeler go into a public identification database, on a deadline tied to the label.
- Where the agency flags submitted information as apparently incorrect, the labeler has thirty days to correct it or explain why it is right.
Frequently asked questions
What are the two parts of a device identifier?
A device identifier is the mandatory fixed portion identifying the specific version or model and the labeler. A production identifier is the conditional variable portion. It identifies the lot or batch, serial number, expiration date or manufacturing date where those appear on the label. For a human cell or tissue product regulated as a device, it carries a distinct identification code instead.
Why does the code appear twice on a package?
Because the rule requires two forms. One is easily readable plain text. The other is automatic identification and data capture technology. The rules define that as any technology conveying the identifier in a form that can be entered into an electronic patient record or other computer system by an automated process. Where that technology is not visually evident, its presence has to be disclosed.
Can an identifier be reused on a different product?
No. A device identifier may be used to identify only one version or model, and where a version or model is discontinued its identifier may not be reassigned to another device. A discontinued model that is reintroduced unchanged may use its previous identifier again.
What forces a new identifier?
A change to a device that results in a new version or model, and the creation of a new device package. Relabeling also does: a relabeler assigns a new device identifier and keeps a record showing the relationship between the prior identifier and the new one.
What information goes into the public database?
Fourteen fields about each version or model. They include the identifier, the proprietary name as labeled and any model number. They include whether it is labeled sterile, its natural rubber latex content and its magnetic resonance safety. And they include size, the types of production identifiers on the label, the premarket submission or exemption status, the listing number, a nomenclature term, and the number of devices in the package. Three further fields identify the labeler and its contact.
Is this the same as the number on a drug package?
No. A national drug code is a listing number for a drug assigned under a different part of the rules. A unique device identifier is issued under a system operated by the agency or an accredited issuing agency, conforms to named international standards, and identifies a device version or model together with its labeler.
Sources
Each document below is named as it names itself, with the date printed on that document rather than the day it was read.
- 21 CFR 830.3 and 830.20 — Definitions including labeler, device package, and the two segments of a unique device identifier, and the technical requirements for an identifier including the incorporated international standards — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026
- 21 CFR 830.40, 830.50 and 830.60 — Use and discontinuation of a device identifier, changes that require a new one, and relabeling with the record linking the prior identifier to the new one — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026
- 21 CFR 830.310, 830.320, 830.330, 830.350 and 830.360 — The fourteen device fields and three labeler fields required for identification, the designated contact and electronic submission, the submission and update deadlines, the thirty-day correction duty, and the three-year record retention — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026
- 21 CFR 801.20, 801.30, 801.40 and 801.45 — Label to bear a unique device identifier, the general exceptions including research, custom, investigational and export devices, the two required forms and the universal product code shortcut, and direct marking of reprocessed devices — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026