Identity
- Trade Name
- AtlanticMED FDA UDI
- Generic Name
- Perineal cooler FDA UDI
- Device Name
- Perineal Instant Cold Pack. Highly absorbent. Adhesive tab. FDA UDI
- Model / Reference
- ATL-PER-0613 FDA UDI
- Description
- Perineal Instant Cold Pack. Highly absorbent. Adhesive tab. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008614667 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Perineal cooler FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Perineal cooler
AtlanticMED by Atlantic Trading LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Atlantic Trading LLC
Sources (1)
- FDA UDI ed7b1d68-8a7d-4b1f-9e27-b2795aedc767 33 fields · synced May 30, 2026