Identity
- Trade Name
- AC Adapter for Vibrating Mesh Nubulizer NE-U22V FDA UDI
- Generic Name
- Basic power supply, reusable FDA UDI
- Device Name
- AC Adapter for Omron Vibrating Mesh Nebulizer NE-U22V FDA UDI
- Model / Reference
- U22-5 FDA UDI
- Description
- AC Adapter for Omron Vibrating Mesh Nebulizer NE-U22V FDA UDI
Identifiers
- Catalog Number
- U22-5 FDA UDI
- Primary DI / UDI-DI
- 00073796512255 FDA UDI
- 510(k) Number
- K062263 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Basic power supply, reusable 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
Yes
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: Basic power supply, reusable
AC Adapter for Vibrating Mesh Nubulizer NE-U22V by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062263 also covers:
- AC Adapter — Omron Healthcare, Inc.
- Mask Adapter — Omron Healthcare, Inc.
- Medication Container — Omron Healthcare, Inc.
- Mesh Cap — Omron Healthcare, Inc.
- Omron Mask and Mouthpiece Adapter — Omron Healthcare, Inc.
- Omron Medication Bottle — Omron Healthcare, Inc.
- Omron Mesh Cap for Nebulizer — Omron Healthcare, Inc.
- Omron Micro Air Vibrating Mesh Nebulizer — Omron Healthcare, Inc.
- Omron MicroAir Vibrating Mesh Nebulizer — Omron Healthcare, Inc.
- Omron Mouthpiece for Vibrating Mesh Nebulizer — Omron Healthcare, Inc.
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
- Omron Healthcare, Inc.
Sources (1)
- FDA UDI e2b68b88-2895-4690-96c9-e88074932ce0 36 fields · synced May 30, 2026