Identity
- Trade Name
- 18PG - Class A - Poly Green FDA UDI
- Generic Name
- Endothermic cold therapy pack FDA UDI
- Device Name
- 18PG - Class A - Poly Green FDA UDI
- Model / Reference
- K615-013 FDA UDI
- Description
- 18PG - Class A - Poly Green FDA UDI
Identifiers
- Catalog Number
- K615-013 FDA UDI
- Primary DI / UDI-DI
- 00766588150130 FDA UDI
- FDA Product Code
- LRR FDA UDIKGX FDA UDIIMD FDA UDICBP FDA UDIEFQ FDA UDIHMP FDA UDI
- GMDN Term
- Endothermic cold therapy pack FDA UDI
Classification
- Device Class
- N FDA UDI
- Regulation Number
- 880.5240 FDA UDI890.5710 FDA UDI868.5870 FDA UDI878.4440 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 padWound-nonadherent dressing, absorbent, non-antimicrobial
18PG - Class A - Poly Green by Certified Safety Manufacturing, Inc. — Class N — 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 N | Pending data |
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Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI e6600550-5603-4ddf-8f56-cd92e38121f1 35 fields · synced Jun 7, 2026