Identity
- Trade Name
- GE Healthcare Airway Gas Sampling Set FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. FDA UDI
- Model / Reference
- Infant, 2m/7ft FDA UDI
- Description
- Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. FDA UDI
Identifiers
- Catalog Number
- 8090121522 FDA UDI
- Primary DI / UDI-DI
- 24251679601528 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Gas-sampling/monitoring respiratory tubing, single-use
GE Healthcare Airway Gas Sampling Set by BluePoint Medical GmbH & Co. KG — Class II — 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
- Thornhill Research Inc. — Thornhill Research Inc · Class I
- 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
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BluePoint Medical GmbH & Co. KG
Sources (1)
- FDA UDI ded6da69-69e5-41f8-870e-72bac19aa035 35 fields · synced May 30, 2026