Identity
- Trade Name
- CPAP Cleaning Kit FDA UDI
- Generic Name
- Medical device disinfection agent FDA UDI
- Device Name
- Citrus CPAP Cleaning Kit This kit contains: 1 CAP1003 Citrus II CPAP Cleaning Wipes Canister 1 CAP1013 CPAP Tube Brush FDA UDI
- Model / Reference
- APAR008CAP1003KIT FDA UDI
- Description
- Citrus CPAP Cleaning Kit This kit contains: 1 CAP1003 Citrus II CPAP Cleaning Wipes Canister 1 CAP1013 CPAP Tube Brush FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530085414 FDA UDI
- FDA Product Code
- EPE FDA UDI
- GMDN Term
- Medical device disinfection agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5795 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
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: Medical device disinfection agent
CPAP Cleaning Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device disinfection agent.
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class I
- Instru Zym — Laboratorium Dr. Deppe GmbH · Class I
- Your First Enzymatic & Non-Enzymatic Sponges — BATRIK MEDICAL MANUFACTURING INC. · Class I
- Rapidzyme PR — Novapharm Research (Australia) Pty Ltd · Class IIb
- Olie Medical Performance Enzymatic 5 — Amity Limited · Class I
- Coltene Biosonic UC40 — Topdental (Products) Ltd · Class I
- Enzymatic Detergent — QUADRALENE LTD · Class I
- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 52e0f7fa-e8c4-47e4-90b5-138b976f4953 34 fields · synced Jun 8, 2026