Identity
- Trade Name
- Puritan HydraFlock FDA UDI
- Generic Name
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
- Device Name
- Absorbent Tipped Applicators, Sterile EUDAMEDSterile Flocked Collection Devices FDA UDI
- Model / Reference
- 25-3316-H EMB 80 BT EUDAMEDFDA UDI
- Description
- Sterile Flocked Collection Devices FDA UDI
Identifiers
- Catalog Number
- 25-3316-H EMB 80 BT FDA UDI
- Primary DI / UDI-DI
- 10609576330916 EUDAMEDFDA UDI
- Basic UDI-DI
- 0609576ATAS29 EUDAMED
- FDA Product Code
- KXG FDA UDI
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
- GMDN Term
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General-purpose absorbent tip applicator/swab, single-use
Puritan HydraFlock by Puritan Medical Products Company Llc — Class I — MDR, 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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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 1946c6c9-35b1-440a-8117-1a817d94fec9 35 fields · synced Jun 19, 2026
- EUDAMED c259fbe2-a01f-4f9f-840e-530e71ea1ee5 61 fields · synced Jun 19, 2026