AccessGUDID - DEVICE: MCN VAC W2 DSF DS G (08592346756854)

GUDID

Device Identifier (DI) Information

Brand Name: MCN VAC W2 DSF DS G
Version or Model: 0731012US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GCE, s.r.o.

Primary DI Number: 08592346756854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 819753190 *Terms of Use

Device Description: Low-pressure hoses are intended for the transfer of medical gases or vacuum, and/or the connection of two medical products (e.g. a pressure regulator with an emergency ventilator).

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
Over the Counter (OTC):	No
Kit:	No
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?
66373	Mixed-respiratory-gas low pressure hose	A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct a specific compressed medical gas mixture (e.g., helium/oxygen, nitrous oxide/oxygen mixture) from a specific terminal unit or cylinder to an appropriate respiratory/ventilatory medical device. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

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: 0e1698d3-d12f-47e8-8b2d-6fda5069c304
Public Version Date: July 28, 2022
Public Version Number: 1
DI Record Publish Date: July 20, 2022