Altrix Temperature Management Wraps
510(k) K171149
Altrix Temperature Management Wraps is a Class II device made by Stryker Medical, cleared under FDA 510(k) K171149 on 18 Jul 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171149 | Date18 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K171149
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DWJ
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5900
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K171149
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Altrix Temperature Management Wraps 3008-002-106 | 8003-002-106 / 3008-002-106 | 07613327374155 | — | On the market |
| Altrix Temperature Management Wraps 8003-002-002 | 8003-002-002 / 8003-002-002 | 07613327374247 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-002-003 | 8003-002-003 / 8003-002-003 | 07613327374254 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-002-004 | 8003-002-004 / 8003-002-004 | 07613327374278 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-002-005 | 8003-002-005 / 8003-002-005 | 07613327374315 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-002-006 | 8003-002-006 / 8003-002-006 | 07613327374285 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-002-101 | 8003-002-101 / 8003-002-101 | 07613327374087 | — | On the market |
| Altrix Temperature Management Wraps 8003-002-102 | 8003-002-102 / 8003-002-102 | 07613327374094 | — | On the market |
| Altrix Temperature Management Wraps 8003-002-103 | 8003-002-103 / 8003-002-103 | 07613327374117 | — | On the market |
| Altrix Temperature Management Wraps 8003-002-104 | 8003-002-104 / 8003-002-104 | 07613327374100 | — | On the market |
| Altrix Temperature Management Wraps 8003-002-105 | 8003-002-105 / 8003-002-105 | 07613327374124 | — | On the market |
| Altrix Temperature Management Wraps 8003-003-001 | 8003-003-001 / 8003-003-001 | 07613327374292 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-003-002 | 8003-003-002 / 8003-003-002 | 07613327374261 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-003-003 | 8003-003-003 / 8003-003-003 | 07613327374308 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-003-004 | 8003-003-004 / 8003-003-004 | 07613327374322 | — | No longer on the market |
| Altrix Temperature Management Wraps 8003-003-101 | 8003-003-101 / 8003-003-101 | 07613327374131 | — | On the market |
| Altrix Temperature Management Wraps 8003-003-102 | 8003-003-102 / 8003-003-102 | 07613327374148 | — | On the market |
| Altrix Temperature Management Wraps 8003-003-103 | 8003-003-103 / 8003-003-103 | 07613327374179 | — | On the market |
| Altrix Temperature Management Wraps 8003-003-104 | 8003-003-104 / 8003-003-104 | 07613327374162 | — | On the market |
| Altrix Temperature Mangement Wraps 8003-002-001 | 8003-002-001 / 8003-002-001 | 07613327374230 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code DWJ (System, Thermal Regulating).
- Arctic Sun® Temperature Management System, Temperature Cable Nellcor 73502 by Medivance, Inc.
- Geratherm SOS-Rescue Blanket by Rg Ent., Inc.
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- Warmtouch Patient Warming System, Model 5300 by Nellcor Puritan Bennett, Inc.
- ALLON 2001 by Mtre Advanced Technology, Ltd.
- Life-Air 1000 Patient Warming Cover by Progressive Dynamics, Inc.
- ACROTHERM by Aquarius Medical Corp.