Identity
- Trade Name
- CPAP Tubing FDA UDI
- Generic Name
- Airway device cleaning utensil, noninvasive, reusable FDA UDI
- Device Name
- CPAP Tube Cleaning Brush – 6 feet FDA UDI
- Model / Reference
- APAR008CAP1013 FDA UDI
- Description
- CPAP Tube Cleaning Brush – 6 feet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530085407 FDA UDI
- FDA Product Code
- EPE FDA UDI
- GMDN Term
- Airway device cleaning utensil, noninvasive, reusable 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
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: Airway device cleaning utensil, noninvasive, reusable
CPAP Tubing by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Airway device cleaning utensil, noninvasive, reusable.
- Provox Life LP Kit 12 - LT 12/36, 12/55 — ATOS MEDICAL INC. · Class II
- AP Onkers — Small Beginnings, Inc. · Class II
- Provox Life LP Kit 16 - LT 10/55-2HSTP — ATOS MEDICAL INC. · Class II
- Provox Life LP Kit 1 - LT 8/36, 8/55 — ATOS MEDICAL INC. · Class II
- Provox Life LP Kit 17 - LT 10/55-2HTTP — ATOS MEDICAL INC. · Class II
- Provox Life LP Kit 10 - LT 9/36, 9/55 — ATOS MEDICAL INC. · Class II
- Grafco — GF Health Products, Inc · Class I
- Trach Tube Cleaning Brushes — Boston Medical Products, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI bb82bdbd-f83d-47ae-8af9-7499157e5dc8 34 fields · synced May 30, 2026