Identity
- Trade Name
- Personal Device Holder FDA UDI
- Generic Name
- Home CPAP/BPAP washer/disinfector device container FDA UDI
- Device Name
- Cylinder Bag - D Tank (Private Labeled J&L) FDA UDI
- Model / Reference
- CSBDPL-JL FDA UDI
- Description
- Cylinder Bag - D Tank (Private Labeled J&L) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530093754 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Home CPAP/BPAP washer/disinfector device container FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 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: Home CPAP/BPAP washer/disinfector device container
Personal Device Holder by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home CPAP/BPAP washer/disinfector device container.
- Carex — COMPASS HEALTH BRANDS CORP. · Class II
- Carex — COMPASS HEALTH BRANDS CORP. · Class II
- Personal Device Holder — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Accessory — 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 2225f2f0-f69c-422f-ae93-1f77ac059650 34 fields · synced May 30, 2026