AccessGUDID - DEVICE: MCN O2 G2 DSF DSF G (08592346756885)

GUDID

Device Identifier (DI) Information

Brand Name: MCN O2 G2 DSF DSF G
Version or Model: 0731003US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GCE, s.r.o.

Primary DI Number: 08592346756885
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?
63209	General-gas low pressure tubing, reusable	A non-sterile length of flexible tube intended to conduct compressed medical gas typically from a cylinder to a respiratory medical device outside of a static clinical environment (e.g., emergency CPAP device); it is not dedicated for use with a specific gas. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 15 bar), having been reduced by a regulator from a high pressure. The tubing is available in various lengths, including standard coil lengths; it is not colour-coded. This is a reusable device.	Obsolete	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: 31004a3b-e653-47c4-9097-4fa1aef01fba
Public Version Date: April 21, 2021
Public Version Number: 1
DI Record Publish Date: April 13, 2021