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VAR (VORTRAN Automatic Resuscitator) with Extension

FDA UDI

Class II (US FDA UDI)

by Vortran Medical Technology 1, Inc.

Identity

Trade Name
VAR (VORTRAN Automatic Resuscitator) with Extension FDA UDI
Generic Name
Pulmonary resuscitator, pneumatic, single-use FDA UDI
Device Name
The VAR® device is a unique single-patient-use, disposable resuscitator. It provides hands-free ventilator support via a mask or endotracheal tube using a continuous gas flow source. The VAR® device can be operated on a compressor, oxygen or compressed air. Since it does not require the use of electricity or batteries, it is an ideal backup ventilator for the management of mass casualty incidents, natural disasters, disease outbreaks, major power outages and other extraordinary emergencies. An additional advantage of the VAR® device is that it does not interfere with MRI and CT scans. FDA UDI
Model / Reference
PCE-5012 FDA UDI
Description
The VAR® device is a unique single-patient-use, disposable resuscitator. It provides hands-free ventilator support via a mask or endotracheal tube using a continuous gas flow source. The VAR® device can be operated on a compressor, oxygen or compressed air. Since it does not require the use of electricity or batteries, it is an ideal backup ventilator for the management of mass casualty incidents, natural disasters, disease outbreaks, major power outages and other extraordinary emergencies. An additional advantage of the VAR® device is that it does not interfere with MRI and CT scans. FDA UDI

Identifiers

Catalog Number
PCE-5012 FDA UDI
Primary DI / UDI-DI
10637320050124 FDA UDI
510(k) Number
K041473 FDA UDI
FDA Product Code
BTL FDA UDI
GMDN Term
Pulmonary resuscitator, pneumatic, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5925 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulmonary resuscitator, pneumatic, single-use

VAR (VORTRAN Automatic Resuscitator) with Extension by Vortran Medical Technology 1, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Pulmonary resuscitator, pneumatic, single-use.

Cleared under the same submission

K041473 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vortran Medical Technology 1, Inc.

Sources (1)

  • FDA UDI 9b713cf5-a247-4479-8f87-b5962277bd47 36 fields · synced Jun 8, 2026