AccessGUDID - DEVICE: VAR Surgical Center Kit (20637320050503)

GUDID

Device Identifier (DI) Information

Brand Name: VAR Surgical Center Kit
Version or Model: PCK-5050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCK-5050
Company Name: VORTRAN MEDICAL TECHNOLOGY 1, INC

Primary DI Number: 20637320050503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 090508636 *Terms of Use

Device Description: Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57981	Pulmonary resuscitator, pneumatic, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc83ae77-e008-45fe-b9ff-9981ce7cbf4c
Public Version Date: October 16, 2019
Public Version Number: 4
DI Record Publish Date: July 14, 2016