Identity
- Trade Name
- Alphamed FDA UDI
- Generic Name
- Therapeutic agent nebulizer, ambulatory FDA UDI
- Model / Reference
- NBM-7B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810021174334 FDA UDI
- 510(k) Number
- K230379 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, ambulatory 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Therapeutic agent nebulizer, ambulatory
Alphamed by Dongguan SIMZO Electronic Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Therapeutic agent nebulizer, ambulatory.
- Roscoe Medical — COMPASS HEALTH BRANDS CORP. · Class II
- Roscoe Medical — COMPASS HEALTH BRANDS CORP. · Class II
- Carex Health Brands — COMPASS HEALTH BRANDS CORP. · Class II
- Carex Health Brands — COMPASS HEALTH BRANDS CORP. · Class II
- Roscoe Medical — COMPASS HEALTH BRANDS CORP. · Class II
- Carex Health Brands — COMPASS HEALTH BRANDS CORP. · Class II
- Carex Health Brands — COMPASS HEALTH BRANDS CORP. · Class II
- Carex Health Brands — COMPASS HEALTH BRANDS CORP. · Class II
Cleared under the same submission
K230379 also covers:
- Airpulse — Dongguan SIMZO Electronic Technology Co., Ltd.
- Balnore — Dongguan SIMZO Electronic Technology Co., Ltd.
- CadeVita — Dongguan SIMZO Electronic Technology Co., Ltd.
- HARTON — Dongguan SIMZO Electronic Technology Co., Ltd.
- RALIMI — Dongguan SIMZO Electronic Technology Co., Ltd.
- SRBCare — Dongguan SIMZO Electronic Technology Co., Ltd.
- SRBCare — Dongguan SIMZO Electronic Technology Co., Ltd.
- WITCAREMED — Shenzhen Witcaremed Medical Technology Co., Ltd
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
- Dongguan SIMZO Electronic Technology Co., Ltd.
Sources (1)
- FDA UDI cacc359e-63a4-4614-b133-c08b9def4b3d 33 fields · synced Jun 1, 2026