Identity
- Trade Name
- DRIVE FDA UDI
- Generic Name
- Tracheostomy mask, aerosol FDA UDI
- Device Name
- Respiratory Respiratory Disposables Product Description Adult Tracheotomy Mask 50/case FDA UDI
- Model / Reference
- MASK 007A FDA UDI
- Description
- Respiratory Respiratory Disposables Product Description Adult Tracheotomy Mask 50/case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50822383138126 FDA UDI
- FDA Product Code
- CAT FDA UDI
- GMDN Term
- Tracheostomy mask, aerosol FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5340 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tracheostomy mask, aerosol
Drive by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HUDSON RCI — TELEFLEX INCORPORATED · Class I
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
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI 6e4891f2-47bb-4811-bdd6-5f0f100dead1 33 fields · synced Jun 8, 2026