VAR (VORTRAN Automatic Resuscitator) with Extension

Primary DI
10637320050124
Brand
VAR (VORTRAN Automatic Resuscitator) with Extension
Company
VORTRAN MEDICAL TECHNOLOGY 1, INC
Model
PCE-5012
Catalog number
PCE-5012
Device 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.
Published
2015-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041473000VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCMVortran Medical Technology 1, Inc.2004-07-15BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20637320050121PackageGS110In Commercial Distribution
10637320050124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063732005012120637320050121
1063732005012410637320050124

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, pneumatic, single-useA non-sterile device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
916-648-8460lweddington@vortran.com

Regulatory Flags#

DUNS number
090508636
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00637320061239VORTRAN GO2VENT® with Peep Valve612361232025-02-20
10637320062004VORTRAN GO2VENT with PEEP Valve620062002021-05-04
20637320062001VORTRAN GO2VENT with PEEP Valve620062002021-05-04
10637320039600VORTRAN® APM-Plus396039602020-01-30
10637320039006VORTRAN Airway Pressure MonitorAPM-3900APM-39002016-06-14
10637320060017VORTRAN GO2VENT600160012019-05-03
10637320000112VORTRAN GO2VENT 660066002019-04-19
20637320050503VAR Surgical Center KitPCK-5050PCK-50502016-07-14
20637320060014VORTRAN GO2VENT600160012019-05-03
10637320000105VORTRAN GO2VENT612361232017-06-07
10637320000167VORTRAN GO2VENT6123-166123-162017-06-07
10637320024507VCI (VORTRAN Cuff Inflator)245024502018-08-31
10637320040200VORTRAN-IPPBIP-4020IP-40202016-06-14
10637320040217VORTRAN-IPPB with Water TrapIPW-4021IPW-40212016-06-14
10637320040224VORTRAN-IPPB with ManomterIPM-4022IPM-40222016-06-14
10637320040309VORTRAN PercussiveNEBPNB-4030PNB-40302016-06-14
10637320050001VAR (VORTRAN Automatic Resuscitator)PT-5000PT-50002015-11-04
10637320050018VAR (VORTRAN Automatic Resuscitator) with ManometerPTM-5001PTM-50012015-11-04
10637320050025VAR (VORTRAN Automatic Resuscitator) with ExtensionPTE-5002PTE-50022015-11-04
10637320050100VAR (VORTRAN Automatic Resuscitator)PC-5010PC-50102015-11-05

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