Identity
- Trade Name
- Circulaire II Aerosol Drug Delivery System FDA UDI
- Generic Name
- Aerosol face mask, rebreathing, single-use FDA UDI
- Device Name
- with VixOne,, nose clip, mouthpiece, adult non-vented mask FDA UDI
- Model / Reference
- 0395 FDA UDI
- Description
- with VixOne,, nose clip, mouthpiece, adult non-vented mask FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078000706 FDA UDI
- 510(k) Number
- K926055 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Aerosol face mask, rebreathing, 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, single-useAerosol face mask, rebreathing, single-use
Circulaire II Aerosol Drug Delivery System by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Aerosol face mask, rebreathing, single-use.
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Cleared under the same submission
K926055 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Circulaire — WESTMED, INC.
- Circulaire II Hybrid Aerosol Drug Delivery System — WESTMED, INC.
- Circulaire II Hybrid Aerosol Drug Delivery System — WESTMED, 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
- Westmed, Inc.
Sources (1)
- FDA UDI c8c9e187-e85a-48ed-98c6-3fba5c2b952c 34 fields · synced May 30, 2026