E-Surge Kit

FDA UDI

by Vortran Medical Technology 1, Inc.

Identity

Trade Name: E-Surge Kit FDA UDI
Generic Name: Pulmonary resuscitator, pneumatic, single-use FDA UDI
Device Name: Kit Includes: 6 each VAR Model PCM-5011, 4 each VAR Monitors; 4 each Oxygen Flowmeters; 1 each Multi-outlet manifold; 1 each 20' Heavy Duty Oxygen Hose; 1 each Watertight Carrying Case; 10 each HME Filters FDA UDI
Model / Reference: ES-4070 FDA UDI
Description: Kit Includes: 6 each VAR Model PCM-5011, 4 each VAR Monitors; 4 each Oxygen Flowmeters; 1 each Multi-outlet manifold; 1 each 20' Heavy Duty Oxygen Hose; 1 each Watertight Carrying Case; 10 each HME Filters FDA UDI

Identifiers

Catalog Number: ES-4070 FDA UDI
Primary DI / UDI-DI: 20637320040702 FDA UDI
GMDN Term: Pulmonary resuscitator, pneumatic, single-use FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary resuscitator, pneumatic, single-use

E-Surge Kit by Vortran Medical Technology 1, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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VAR (VORTRAN Automatic Resuscitator) — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
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VORTRAN GO2VENT — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
VAR (VORTRAN Automatic Resuscitator) — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
VORTRAN GO2VENT — VORTRAN MEDICAL TECHNOLOGY 1, INC. · 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	N/A	Pending data

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Manufacturer

Manufacturer: Vortran Medical Technology 1, Inc.

Sources (1)

FDA UDI c26148bb-a013-49b1-b339-a8f95cd95895 35 fields · synced May 30, 2026