Identity
- Trade Name
- 16PW - Century Link - Poly Green FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Device Name
- 16PW - Century Link - Poly Green FDA UDI
- Model / Reference
- K615-061 FDA UDI
- Description
- 16PW - Century Link - Poly Green FDA UDI
Identifiers
- Catalog Number
- K615-061 FDA UDI
- Primary DI / UDI-DI
- 00766588150611 FDA UDI
- FDA Product Code
- IMD FDA UDIEFQ FDA UDIKGX FDA UDICBP FDA UDILRR FDA UDI
- GMDN Term
- Non-rebreathing valve, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 FDA UDI880.5240 FDA UDI868.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: First aid kit, medicatedAdhesive bandageNon-woven gauze padDressing-fixation skin adhesive tape, non-silicone
16PW - Century Link - Poly Green by Certified Safety Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endothermic cold therapy pack.
- Ice Compress 4"x7" — DISTRIBUTION UNLIMITED, LLC · Class I
- Basic — Intco Medical Industries, Inc. · Class I
- Medi-First Cold Compress Large — Medique Products · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Uline 25 Person First Aid Kit - SUB — ULINE, INC. · N
- Uline 50 Person First Aid Kit - SUB — ULINE, INC. · N
- First Aid Only — ACME UNITED CORP. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI d6d7d17a-d320-4ab2-9631-b309310e6259 35 fields · synced Jun 1, 2026