Identity
- Trade Name
- VCI (VORTRAN Cuff Inflator) FDA UDI
- Generic Name
- Endotracheal tube cuff inflator FDA UDI
- Device Name
- The VORTRAN® Cuff Inflator (VCI) is a hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes. FDA UDI
- Model / Reference
- 2450 FDA UDI
- Description
- The VORTRAN® Cuff Inflator (VCI) is a hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes. FDA UDI
Identifiers
- Catalog Number
- 2450 FDA UDI
- Primary DI / UDI-DI
- 10637320024507 FDA UDI
- 510(k) Number
- K173914 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endotracheal tube cuff inflator
VCI (VORTRAN Cuff Inflator) by Vortran Medical Technology 1, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube cuff inflator.
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- AincA® — Anesthesia Associates, Inc. · Class II
- IntelliCuff — HAMILTON MEDICAL, INC. · Class II
- TRACOE technic — Tracoe medical GmbH · Class II
- Ambu A/S — VBM Medizintechnik GmbH · Class II
- AG Cuffill Kruuse - VET — HOSPITECH RESPIRATION LTD · Class II
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
- Vortran Medical Technology 1, Inc.
Sources (1)
- FDA UDI e72e2323-4625-4882-bc55-d3a87a5f749e 36 fields · synced May 30, 2026