AccessGUDID - DEVICE: Ultipor™ Anesthesia Breathing Circuit System

GUDID

Device Identifier (DI) Information

Brand Name: Ultipor™ Anesthesia Breathing Circuit System - Patient Kit
Version or Model: VMPKXL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VMPKXL
Company Name: Global Life Sciences Solutions USA LLC

Primary DI Number: 00636207315380
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 011658242 *Terms of Use

Device Description: Extra-Large Vanilla-Scented Adult Face Mask, Ported Elbow, and Ultipor 25 Filter. Non-Conductive, Disposable.

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?
62128	Patient-end respiratory anaesthesia kit	A collection of non-sterile devices intended to create a hygienic connection between a patient’s airway and an anaesthesia breathing circuit. It is primarily intended for use with a reusable breathing circuit and typically includes an anaesthesia mask, a tube/mask breathing circuit connector and a microbial medical gas filter. This is a single-patient 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
Device Size Text, specify: Minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.

Device Record Status

Public Device Record Key: 8196a3c1-2b50-478e-b098-31830c95f0cf
Public Version Date: July 26, 2024
Public Version Number: 5
DI Record Publish Date: June 29, 2016