AccessGUDID - DEVICE: Venner™ Tracheal Seal Monitor Extension Tube (08885009190851)

GUDID

Device Identifier (DI) Information

Brand Name: Venner™ Tracheal Seal Monitor Extension Tube
Version or Model: 903001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 903001
Company Name: VENNER MEDICAL (SINGAPORE) PTE. LTD.

Primary DI Number: 08885009190851
Issuing Agency: GS1
Commercial Distribution End Date: February 25, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 659177273 *Terms of Use

Device Description: For facilitating the cuff inflation connection between the Venner™ Tracheal Seal Monitor and Venner™ PneuX P.Y.™ Endotracheal or Tracheostomy breathing tube.

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:	Yes
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?
40484	Medical air low pressure hose	A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed medical air from a medical air cylinder/terminal unit to a medical device that functions with medical air (e.g., ventilator, anaesthesia unit, anaesthesia system, suctions system, or other medical air dependent device). The gas pressure in the tubing will be low, a "working pressure", having been reduced by a regulator from a higher 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: Yes
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: 0e8a0b9f-de54-454d-b951-e8291d48bfcd
Public Version Date: July 04, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
28885009190855	10	18885009190858	2019-02-25	Not in Commercial Distribution	10 boxes in a carton
18885009190858	10	08885009190851	2019-02-25	Not in Commercial Distribution	10 pouches in a box