Identity
- Trade Name
- Oxygen Connector/Adapter FDA UDI
- Generic Name
- Artificial airway cuff inflation tubing FDA UDI
- Device Name
- Oxygen Enrichment Adapter - Bulk FDA UDI
- Model / Reference
- RES019NS FDA UDI
- Description
- Oxygen Enrichment Adapter - Bulk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530060343 FDA UDI
- FDA Product Code
- BZA FDA UDI
- GMDN Term
- Artificial airway cuff inflation tubing 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Artificial airway cuff inflation tubing
Oxygen Connector/Adapter by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Artificial airway cuff inflation tubing.
- TRACOE technic — Tracoe medical GmbH · Class II
- SunMed — SunMed · Class II
- Venner PneuX TSM™ Extension Tube(non-sterile) — VENNER MEDICAL (SINGAPORE) PTE. LTD. · Class I
- Oxygen Connector — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Respiratory Accessory — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Respiratory Accessory — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Oxygen Accessories — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Respiratory Accessory — SUNSET HEALTHCARE SOLUTIONS, Inc. · 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 |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 4a5c8205-99b4-4874-9fed-b9c8685fdb6f 34 fields · synced May 30, 2026