Identity
- Trade Name
- Unite Medical® FDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- The Unite Medical® Cryo Pneumatic Shoulder orthosis combines pneumatic compression with cold therapy in a universal design. Indicated for post-op application or as an adjuct to a physical therapy regime, the Cryo Pneumatic Shoulder orthosis offers a wide variety of treatment options. Aids in the reduction of swelling, reduced muscle spasms, and pain relief. FDA UDI
- Model / Reference
- Cryo Pneumatic Shoulder - Universal FDA UDI
- Description
- The Unite Medical® Cryo Pneumatic Shoulder orthosis combines pneumatic compression with cold therapy in a universal design. Indicated for post-op application or as an adjuct to a physical therapy regime, the Cryo Pneumatic Shoulder orthosis offers a wide variety of treatment options. Aids in the reduction of swelling, reduced muscle spasms, and pain relief. FDA UDI
Identifiers
- Catalog Number
- Cyro3670 FDA UDI
- Primary DI / UDI-DI
- 00850012035312 FDA UDI
- FDA Product Code
- IQQ FDA UDI
- GMDN Term
- Hot/cold therapy pack, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hot/cold therapy pack, reusableShoulder immobilizer/orthosis, reusable
Unite Medical® by Unite Medical, Llc — 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
- Unite Medical, Llc
Sources (1)
- FDA UDI 76d4d2a9-498a-4b00-a4d3-e375a30af162 35 fields · synced Jun 8, 2026