AccessGUDID - DEVICE: Ultipor™ Anesthesia Breathing Circuit System

GUDID

Device Identifier (DI) Information

Brand Name: Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit
Version or Model: VM40COAX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VM40COAX
Company Name: Global Life Sciences Solutions USA LLC

Primary DI Number: 00636207315199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011658242 *Terms of Use

Device Description: Adult 40" Uni-Limb (Coaxial) Circuit with Expiratory Tubing attached @ 3-Way Inspiratory Port, 0.060" ID CO2 Gas Sampling Line, and 3 Liter Non-Latex Breathing Bag.

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":	Yes
For Single-Use:	Yes
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?
37021	Anaesthesia breathing circuit, reusable	An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAH	Filter, bacterial, breathing-circuit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013093	000

Device Exempt from Premarket Submission: No 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
Length: 40 Inch

Device Record Status

Public Device Record Key: ddcf9891-6865-46a2-a15e-53afd3f8f986
Public Version Date: February 29, 2024
Public Version Number: 5
DI Record Publish Date: June 29, 2016