Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Moist-cold pack FDA UDI
- Device Name
- A single squeeze activation makes this cold therapy pack immediately reach a safe, therapeutic temperature (0°C) and sustain this temperature for up to 15 minutes. - Sized 12 x 14 cm, it offers full coverage of the surgical area. - Easy to store and use: Simply keep at ambient temperature, no need for a freezer FDA UDI
- Model / Reference
- HY-303 FDA UDI
- Description
- A single squeeze activation makes this cold therapy pack immediately reach a safe, therapeutic temperature (0°C) and sustain this temperature for up to 15 minutes. - Sized 12 x 14 cm, it offers full coverage of the surgical area. - Easy to store and use: Simply keep at ambient temperature, no need for a freezer FDA UDI
Identifiers
- Catalog Number
- HY-303 FDA UDI
- Primary DI / UDI-DI
- 03615140000451 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Moist-cold 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Moist-cold pack
Hygitech by Hygitech — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI 03be7d75-e795-4227-9dae-eb25680cb478 34 fields · synced May 30, 2026