Identity
- Trade Name
- Venner™ Tracheal Seal Monitor FDA UDI
- Generic Name
- Endotracheal tube cuff inflator FDA UDI
- Device Name
- An electro-mechanical system for the control of air pressure within the inflation cuff of an Venner™ PneuX P.Y.™ Endotracheal or Tracheostomy tube. FDA UDI
- Model / Reference
- 903200 FDA UDI
- Description
- An electro-mechanical system for the control of air pressure within the inflation cuff of an Venner™ PneuX P.Y.™ Endotracheal or Tracheostomy tube. FDA UDI
Identifiers
- Catalog Number
- 903200 FDA UDI
- Primary DI / UDI-DI
- 08885009190707 FDA UDI
- FDA Product Code
- BSK FDA UDI
- GMDN Term
- Endotracheal tube cuff inflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5750 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endotracheal tube cuff inflator
Venner™ Tracheal Seal Monitor by Venner Medical (singapore) Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Venner Medical (singapore) Pte. Ltd.
Sources (1)
- FDA UDI ef106f31-5a60-4d26-8108-bfcdb11398fb 35 fields · synced May 30, 2026