Venner™ Tracheal Seal Monitor Extension Tube

Basic Information

• Brand Name: Venner™ Tracheal Seal Monitor Extension Tube
• Primary DI: 08885009190851
• Version / Model: 903001
• Catalog Number: 903001
• Company Name: VENNER MEDICAL (SINGAPORE) PTE. LTD.
• Labeler DUNS: 659177273
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 0e8a0b9f-de54-454d-b951-e8291d48bfcd
• Distribution End Date: 2019-02-25

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28885009190855	GS1	10 boxes in a carton	10	Not in Commercial Distribution	2019-02-25
Package	18885009190858	GS1	10 pouches in a box	10	Not in Commercial Distribution	2019-02-25
Primary	08885009190851	GS1