Identity
- Trade Name
- Aptima Unisex Specimen Collection Swab FDA UDI
- Generic Name
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
- Device Name
- The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit. FDA UDI
- Model / Reference
- CD215 FDA UDI
- Description
- The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit. FDA UDI
Identifiers
- Catalog Number
- CD215 FDA UDI
- Primary DI / UDI-DI
- 00862255000347 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose absorbent tip applicator/swab, single-use
Aptima Unisex Specimen Collection Swab by MML Diagnostics Packaging, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MML Diagnostics Packaging, Inc.
Sources (1)
- FDA UDI b1c68407-df91-476b-9974-218710a50074 35 fields · synced Jun 9, 2026