AccessGUDID - DEVICE: Anesthesia Breathing Circuit Kit (06941850890271)

GUDID

Device Identifier (DI) Information

Brand Name: Anesthesia Breathing Circuit Kit
Version or Model: KB0101A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TYPENEX MEDICAL LLC

Primary DI Number: 06941850890271
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600850213 *Terms of Use

Device Description: Adult Anesthesia Breathing Circuit Kit - 90" Dual Limb Breathing Circuit - Bacterial Viral Filter - Size 5 Anesthesia Mask - 3L Breathing Bag - 10 ft Gas Sampling Line

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):	No
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?
37704	Anaesthesia breathing circuit, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 39 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7edd9f7-7342-4861-a852-285ea24aee85
Public Version Date: June 05, 2024
Public Version Number: 2
DI Record Publish Date: May 08, 2024