AccessGUDID - DEVICE: 30MM UNIFLOW COAXIAL BS WITH ELBOW INTEGRAL MONITORING LINE AND LIMB, 1.6M (05030267065431)

GUDID

Device Identifier (DI) Information

Brand Name: 30MM UNIFLOW COAXIAL BS WITH ELBOW INTEGRAL MONITORING LINE AND LIMB, 1.6M
Version or Model: 2902000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intersurgical Incorporated

Primary DI Number: 05030267065431
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785952607 *Terms of Use

Device Description: 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH ELBOW, INTEGRAL MONITORING LINE, AND LIMB, 1.6M

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53197989-752a-40fe-97d2-628f744ab8b7
Public Version Date: February 11, 2025
Public Version Number: 4
DI Record Publish Date: October 15, 2021