Identity
- Trade Name
- Oxygen Kit FDA UDI
- Generic Name
- Artificial airway cuff inflation tubing FDA UDI
- Device Name
- Invacare Perfect O2 kit with Humidifier- OF9004 (1), BFH6S (1), BF1438 (1), RES050 (1), HUM008 (1) FDA UDI
- Model / Reference
- APAR008PERFECTOKITB FDA UDI
- Description
- Invacare Perfect O2 kit with Humidifier- OF9004 (1), BFH6S (1), BF1438 (1), RES050 (1), HUM008 (1) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530083946 FDA UDI
- GMDN Term
- Artificial airway cuff inflation tubing FDA UDI
Classification
- 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
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: Artificial airway cuff inflation tubing
Oxygen Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — 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.
- Oxygen Connector/Adapter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Respiratory Accessory — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Oxygen Accessories — 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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 009a5e0d-0666-4cbf-b484-8a8da1f135f6 34 fields · synced May 30, 2026