Identity
- Trade Name
- Oxygen Tubing Swivel Connector Kit FDA UDI
- Generic Name
- Low-pressure tubing connector, reusable FDA UDI
- Device Name
- This kit contains: 1 RES018 Oxygen Tubing Connector - Swivel, 1 RES018ANS Oxygen Tubing Swivel Connector - Male to Female. FDA UDI
- Model / Reference
- RES018KIT-1 FDA UDI
- Description
- This kit contains: 1 RES018 Oxygen Tubing Connector - Swivel, 1 RES018ANS Oxygen Tubing Swivel Connector - Male to Female. FDA UDI
Identifiers
- Catalog Number
- RES018KIT-1 FDA UDI
- Primary DI / UDI-DI
- 00848530061890 FDA UDI
- FDA Product Code
- BZA FDA UDI
- GMDN Term
- Low-pressure tubing connector, reusable 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Category: Low-pressure tubing connector, reusable
Oxygen Tubing Swivel Connector Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 264de34b-7c86-4f11-a5d2-2880e06eeb8c 35 fields · synced May 30, 2026