AccessGUDID - DEVICE: Ultipor™ 25 Anesthesia Breathing Circuit System Filter (00636207302984)

GUDID

Device Identifier (DI) Information

Brand Name: Ultipor™ 25 Anesthesia Breathing Circuit System Filter
Version or Model: BB25AB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BB25AB
Company Name: Global Life Sciences Solutions USA LLC

Primary DI Number: 00636207302984
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011658242 *Terms of Use

Device Description: Ultipor™ 25 Anesthesia Breathing Circuit System Filter with Monitoring Port

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:	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?
46816	Heat/moisture exchanger/microbial medical gas filter	A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use 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: 14ff099c-1271-4643-851b-3e9fbaef23cc
Public Version Date: February 29, 2024
Public Version Number: 5
DI Record Publish Date: June 29, 2016