Identity
- Trade Name
- Omron A.I.R..S. Nebulizer FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- Nebulizer FDA UDI
- Model / Reference
- 9911 FDA UDI
- Description
- Nebulizer FDA UDI
Identifiers
- Catalog Number
- 9911 FDA UDI
- Primary DI / UDI-DI
- 00073796099114 FDA UDI
- 510(k) Number
- K870027 FDA UDI
- FDA Product Code
- CCQ FDA UDI
- GMDN Term
- Nebulizing system delivery set, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5640 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Nebulizing system delivery set, single-useNebulizing system delivery set, reusable
Omron A.I.R..S. Nebulizer by Omron Healthcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nebulizing system delivery set, reusable.
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Cleared under the same submission
K870027 also covers:
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
- Salter AIRE Elite — SALTER LABS
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
- Omron Healthcare, Inc.
Sources (1)
- FDA UDI a798a91a-2a95-4822-b9b6-0329c358a52a 37 fields · synced May 30, 2026