Sarns Warmer, Part #164975 and #164980
510(k) K873813
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873813 | Date6 Nov 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sarns Warmer, Part Numbers 164975 and 164980, is a temperature controller designed for use in cardiopulmonary bypass procedures. Classified as a Class II medical device under FDA product code DWC, it regulates and maintains precise temperature levels for blood and fluids during surgical interventions requiring circulatory support. This device is intended to ensure optimal thermal management to support patient stability during complex cardiovascular operations.
Supplied as a reusable device, the Sarns Warmer is intended for use in controlled clinical environments such as operating rooms and cardiac catheterization labs. It operates under regulatory oversight as a substantially equivalent device to prior generations, with FDA clearance granted under 510(k) number K873813. The device adheres to special controls for cardiovascular temperature control systems and is not intended for MRI use. Storage and maintenance instructions are manufacturer-specific but typically require adherence to sterile or cleanroom protocols as part of its reusable lifecycle.
Other devices from 3M Health Care, Sarns
Questions
AI-generated answers, 1 Oct 2026
What is the Sarns Warmer #164975 and #164980 used for?
The Sarns Warmer, Part Numbers 164975 and 164980, is a temperature controller specifically designed for cardiopulmonary bypass procedures. It regulates and maintains precise temperature levels for blood and fluids during surgeries requiring circulatory support, ensuring optimal thermal management to support patient stability during complex cardiovascular operations.
Is the Sarns Warmer reusable or single-use?
The Sarns Warmer is supplied as a reusable device. It is intended for use in controlled clinical environments such as operating rooms and cardiac catheterization labs, where it undergoes maintenance and cleaning as part of its lifecycle. Manufacturer-specific protocols typically require adherence to sterile or cleanroom standards during storage and maintenance.
What storage and maintenance protocols should be followed for the Sarns Warmer?
Storage and maintenance instructions for the Sarns Warmer are manufacturer-specific but generally require adherence to sterile or cleanroom protocols. Since it is reusable, it must be cleaned, disinfected, and inspected according to the manufacturer’s guidelines to ensure proper functionality and patient safety. These protocols help maintain the device’s performance and longevity in clinical settings.
Are there different models or sizes available for the Sarns Warmer?
The Sarns Warmer is available in two distinct part numbers: 164975 and 164980. While the exact differences between these models are not specified in the provided data, they are both designed for the same primary purpose—temperature control during cardiopulmonary bypass procedures. For specific variations or compatibility, refer to the manufacturer’s documentation.
Can the Sarns Warmer be used in an MRI environment?
No, the Sarns Warmer is explicitly not intended for MRI use. This limitation is noted in the device’s regulatory documentation, which emphasizes its design for controlled clinical environments such as operating rooms and cardiac catheterization labs, where MRI compatibility is not required.