Identity
- Trade Name
- Circulaire FDA UDI
- Generic Name
- Tracheostomy mask, aerosol FDA UDI
- Device Name
- Circulaire Aerosol Masks FDA UDI
- Model / Reference
- 0290 FDA UDI
- Description
- Circulaire Aerosol Masks FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078009136 FDA UDI
- 510(k) Number
- K926055 FDA UDI
- FDA Product Code
- BYG FDA UDICAF FDA UDI
- GMDN Term
- Tracheostomy mask, aerosol FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI868.5630 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: Tracheostomy mask, aerosol
Circulaire by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy mask, aerosol.
- Vital Signs™ — VYAIRE MEDICAL, INC. · Class I
- MedSource Tracheostomy Mask — MEDSOURCE INTERNATIONAL LLC · Class I
- Vital Signs™ — VYAIRE MEDICAL, INC. · Class I
- Trach O-Life — CUTTING EDGE HC BRANDS LLC · Class I
- AirLife™ — Airlife, Inc. · Class I
- AMSure® Tracheostomy Mask — AMSINO INTERNATIONAL, INC. · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
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 II Aerosol Drug Delivery System — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Westmed, Inc.
Sources (1)
- FDA UDI e67e6490-2805-4773-ac1d-86c56e6a89a0 34 fields · synced Jun 1, 2026