Identity
- Trade Name
- Puritan UniTranz-RT FDA UDI
- Generic Name
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
- Device Name
- Collection & Transport System, Non-Sterile EUDAMEDPuritan UniTranz-RT 3ml Filled Vial and 6" Sterile Mini-tip Flock Swab FDA UDI
- Model / Reference
- UT-316 EUDAMEDFDA UDI
- Description
- Puritan UniTranz-RT 3ml Filled Vial and 6" Sterile Mini-tip Flock Swab FDA UDI
Identifiers
- Catalog Number
- UT-316 FDA UDI
- Primary DI / UDI-DI
- 00609576900068 EUDAMED30609576900069 FDA UDI
- Basic UDI-DI
- 0609576TMNSCD3L EUDAMED
- FDA Product Code
- LIO FDA UDI
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
- GMDN Term
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2900 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General-purpose absorbent tip applicator/swab, single-use
Puritan UniTranz-RT by Puritan Medical Products Company Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
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- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Puritan Medical Products Company Llc
Sources (2)
- FDA UDI 946d7a5a-384b-4aec-86d5-74ba83bb428f 36 fields · synced Aug 1, 2026
- EUDAMED a2a99da9-68b8-4420-bd4c-b5e4cad6fe81 61 fields · synced Jul 28, 2026