Identity
- Trade Name
- Bag for Compressor Nebulizer FDA UDI
- Generic Name
- Personal device holder, reusable FDA UDI
- Device Name
- Bag for Compressor Nebulizer FDA UDI
- Model / Reference
- NEB100-BAG FDA UDI
- Description
- Bag for Compressor Nebulizer FDA UDI
Identifiers
- Catalog Number
- NEB100-BAG FDA UDI
- Primary DI / UDI-DI
- 00848530087968 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Personal device holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 FDA UDI
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Personal device holder, reusable
Bag for Compressor Nebulizer by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Personal device holder, reusable.
- TruLock — H R Pharmaceuticals, Inc. · Class I
- SJM™ — ST. JUDE MEDICAL, INC. · Class III
- Leg Bag Holder Small — FLEXICARE MEDICAL LIMITED · Class I
- CADD — ICU MEDICAL, INC. · Class II
- Kangaroo — Cardinalhealth · Class I
- Conveen — Coloplast A/S · Class I
- Axonics — AXONICS MODULATION TECHNOLOGIES, INC. · Class III
- PNS Wearable Accessory L/XL Vertical — STIMWAVE TECHNOLOGIES INCORPORATED · Class II
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 bbbb95e2-5f2c-4e55-bf78-c879ed7d4aa5 35 fields · synced Jun 7, 2026