AccessGUDID - DEVICE: MEDADV (00819667020197)

GUDID

Device Identifier (DI) Information

Brand Name: MEDADV
Version or Model: M409
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M409
Company Name: MEDAS INC

Primary DI Number: 00819667020197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080593067 *Terms of Use

Device Description: DISPOSABLE CO-AXIAL ANAESTHESIA BREATHING CIRCUIT, T PIECE CONNECTOR, ADULT 30MM, 60", 2 L LATEX FREE RESERVOIR BAG

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?
62728	Anaesthesia breathing circuit, single-use, sterile	A sterile assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient, typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are devices also typically employed in the circuit but may not be a part of this device. This is a single-use device.	Obsolete	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: Yes
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: 6d97ed70-05e2-4f89-83e4-2ac037fcdf73
Public Version Date: May 11, 2018
Public Version Number: 1
DI Record Publish Date: April 10, 2018