Identity
- Trade Name
- Sunset Flex HME FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- Sunset Flex HME FDA UDI
- Model / Reference
- RES027FLEX FDA UDI
- Description
- Sunset Flex HME FDA UDI
Identifiers
- Catalog Number
- RES027FLEX FDA UDI
- Primary DI / UDI-DI
- 00848530089054 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Heat/moisture exchanger, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Heat/moisture exchanger, single-use
Sunset Flex HME by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heat/moisture exchanger, single-use.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- AirLife™ — VYAIRE MEDICAL, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- InHealth Technologies; Blom-Singer; EasyFlow — FREUDENBERG MEDICAL, LLC · Class I
- Procure — Twin Med, LLC · Class II
- iCOR — TELEFLEX INCORPORATED · Class I
- BIOPSYBELL SRL — BIOPSYBELL SRL · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 6f33176b-1c1a-45fa-9f07-4b46e14ba634 34 fields · synced May 30, 2026