Identity
- Trade Name
- Custom Medical Specialties, Inc. FDA UDI
- Generic Name
- Endothermic cold therapy pack FDA UDI
- Device Name
- Instant Ice Pack - Non-Sterile FDA UDI
- Model / Reference
- CMS-702 FDA UDI
- Description
- Instant Ice Pack - Non-Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815849022010 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Endothermic cold therapy pack 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endothermic cold therapy pack
Custom Medical Specialties, Inc. by Custom Assemblies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endothermic cold therapy pack.
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · Class I
- 36M - Class B Select - Metal — Certified Safety Manufacturing, Inc. · Class I
- EMT - Duke Energy TD - Red Bag — Certified Safety Manufacturing, Inc. · Class II
- FAC-3 - Lawson Class B — Certified Safety Manufacturing, Inc. · N
- FAC-3 - Class B + Meds - 3 Shelf Cabinet — Certified Safety Manufacturing, Inc. · Class I
- 24M - Salt River Project-21 - Metal — Certified Safety Manufacturing, Inc. · 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
- Custom Assemblies, Inc.
Sources (1)
- FDA UDI 403b53d9-2e0e-45b6-b109-f55d2d4e8706 33 fields · synced Jun 6, 2026