Identity
- Trade Name
- Invacare Perfect O2 Kit FDA UDI
- Generic Name
- Anaesthesia conduction filter FDA UDI
- Device Name
- This kit contains: 1 OF9004 Foam Cabinet Filters, 1 BFH6S HEPA FIlter. FDA UDI
- Model / Reference
- OF9004SP-1A FDA UDI
- Description
- This kit contains: 1 OF9004 Foam Cabinet Filters, 1 BFH6S HEPA FIlter. FDA UDI
Identifiers
- Catalog Number
- OF9004SP-1A FDA UDI
- Primary DI / UDI-DI
- 00848530081614 FDA UDI
- GMDN Term
- Anaesthesia conduction filter FDA UDI
Classification
- 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: Anaesthesia conduction filter
Invacare Perfect O2 Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia conduction filter.
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- Covidien NPB 492A Style Foam Cabinet Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Covidien NPB 492A Style Foam Cabinet Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Oxygen Filters — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 70e6a69f-90cd-4ce5-9976-d3dbb4aba3e5 35 fields · synced Jun 8, 2026