Identity
- Trade Name
- Altrix Temperature Management Wraps FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system pad, single-use FDA UDI
- Model / Reference
- 8003-002-005 FDA UDI
Identifiers
- Catalog Number
- 8003-002-005 FDA UDI
- Primary DI / UDI-DI
- 07613327374315 FDA UDI
- 510(k) Number
- K171149 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- External circulating-fluid core temperature regulation system pad, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: External circulating-fluid core temperature regulation system pad, single-use
Altrix Temperature Management Wraps by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171149 also covers:
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
- Altrix Temperature Management Wraps — Stryker Corp.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 3022d976-95aa-4f41-a51d-5e0c54b4c06b 35 fields · synced Jun 6, 2026