Identity
- Trade Name
- UNIVERSAL F® FLEX FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Universal F Flex Circuit FDA UDI
- Model / Reference
- UF270-61Z-16 FDA UDI
- Description
- Universal F Flex Circuit FDA UDI
Identifiers
- Catalog Number
- UF270-61Z-16 FDA UDI
- Primary DI / UDI-DI
- 00612649210087 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
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
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: Gas-sampling/monitoring respiratory tubing, single-use
Universal F® Flex by King Systems Corporation. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gas-sampling/monitoring respiratory tubing, single-use.
- NomoLine™ Infant/Neonatal Airway Adapter Set with Luer — MASIMO CORPORATION · Class II
- HydroFit Hydrocolloid Adhesive Housing, Oval Extra, 30pk — FREUDENBERG MEDICAL, LLC · Class I
- CAPNOGRAPHY CONNECTOR W/10FT LINE + SLIP LUER FILTER — FLEXICARE MEDICAL LIMITED · Class II
- Classic RT 12 White 10F&15M/10F&15M 1.50m — Plastiflex Group NV · Class IIa
- Perma Pure — Perma Pure, LLC · Class II
- PERMA PURE — Perma Pure, LLC · Class II
- Regular Tape Discs, Std, 30 pack — Freudenberg Medical LLC · Class I
- LiteAire BASIC — THAYER MEDICAL CORPORATION · 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
- King Systems Corporation.
Sources (1)
- FDA UDI ba1bc21b-00b3-4806-a8ba-209723652249 36 fields · synced May 31, 2026