Sims Level 1, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Sims Level 1, Inc. makes
Sims Level 1, Inc. manufactures medical fluid warmers, including the HOTLINE 2 FLUID WARMER, which heats intravenous and irrigation fluids for patient administration. The company also produces the SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, a device designed to maintain neonatal or pediatric patient body temperature during procedures or transport.
These devices are classified as Class II under US regulations and are listed via the FDA’s 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Hotline 2 Fluid Warmer Ref K001764
Regimes: 510(k) Registry: 510(k)Snuggle Warm 4000 Convective Warming System Ref K011907
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sims Level 1, Inc. have in the registry?
The registry currently lists 2 devices for Sims Level 1, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sims Level 1, Inc.'s devices?
Among its 2 most recently registered devices, Sims Level 1, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sims Level 1, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sims Level 1, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sims Level 1, Inc. in the registry?
The most recently registered devices listed for Sims Level 1, Inc. include HOTLINE 2 FLUID WARMER and SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM.