Identity
- Trade Name
- CPAP Carry Bag for ResMed AirSense 11 FDA UDI
- Generic Name
- Medical bag FDA UDI
- Device Name
- CPAP Carry Bag FDA UDI
- Model / Reference
- CAP1028-S11 FDA UDI
- Description
- CPAP Carry Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530106713 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Medical bag FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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: Medical bag
CPAP Carry Bag for ResMed AirSense 11 by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical bag.
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 II | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI d0ff7153-baa3-41d1-9ff2-578b95d6a081 34 fields · synced Jun 8, 2026