Identity
- Trade Name
- HOPE Nebulizer - Adult Kit FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- Adult Nebulizer Kit with 6' Aerosol Tubing, Contains 10 Units FDA UDI
- Model / Reference
- 11320 FDA UDI
- Description
- Adult Nebulizer Kit with 6' Aerosol Tubing, Contains 10 Units FDA UDI
Identifiers
- Catalog Number
- 11320 FDA UDI
- Primary DI / UDI-DI
- 00850008733000 FDA UDI
- 510(k) Number
- K980407 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, single-use
HOPE Nebulizer - Adult Kit by B & B Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K980407 also covers:
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
- B & B Medical Technologies, Inc.
Sources (1)
- FDA UDI f2b32a82-07b0-477c-ba94-e443ca26f924 35 fields · synced May 30, 2026