Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Oxygen administration kit FDA UDI
- Device Name
- Oxygen Barb Size 3/4" O.D. FDA UDI
- Model / Reference
- IPN049455 FDA UDI
- Description
- Oxygen Barb Size 3/4" O.D. FDA UDI
Identifiers
- Catalog Number
- 395552 FDA UDI
- Primary DI / UDI-DI
- 34026704624196 FDA UDI
- FDA Product Code
- BZA FDA UDI
- GMDN Term
- Oxygen administration kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5810 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oxygen administration kit
Rusch by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen administration kit.
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- MedSource Life Support Kit — MEDSOURCE INTERNATIONAL LLC
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Cylinder Wrench for Tank Valve - Without Chain — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
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
- Teleflex Incorporated
Sources (1)
- FDA UDI ba4ff8ff-2243-4280-89d4-e0fb190189db 35 fields · synced May 30, 2026