AccessGUDID - DEVICE: Starter Kit Anesthesia, Adult (07325710003022)

GUDID

Device Identifier (DI) Information

Brand Name: Starter Kit Anesthesia, Adult
Version or Model: 6696810
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Maquet Critical Care AB

Primary DI Number: 07325710003022
Issuing Agency: GS1
Commercial Distribution End Date: September 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 632707092 *Terms of Use

Device Description: Following Device Identifier numbers are included in this KIT: 17325710002244, 17325710004576, 17325710002466

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":	No
For Single-Use:	No
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
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: 8fc72695-b291-4103-a9eb-20bf9c44c9e3
Public Version Date: October 24, 2022
Public Version Number: 4
DI Record Publish Date: November 27, 2015