AccessGUDID - DEVICE: MIDAS, REM, 60%-W-O2, EAVS (00816711024767)

GUDID

Device Identifier (DI) Information

Brand Name: MIDAS, REM, 60%-W-O2, EAVS
Version or Model: 6140-EAVS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6140-EAVS
Company Name: PARKER-HANNIFIN CORPORATION

Primary DI Number: 00816711024767
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004175550 *Terms of Use

Device Description: Midas Flowmeter, Remote, 60% Max, O2 Control+ eAVS

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:	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?
44159	Oxygen/air/nitrous oxide breathing gas mixer	An independent mechanical device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. The mixer receives all three gases from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. It usually delivers the gases with adjustable N2O or air concentrations and ensures a minimum O2 level to the patient through a face mask, mouthpiece, or endotracheal (ET) tube. It is used to improve O2 uptake and/or relieve pain throughout a hospital, during dental procedures, or in obstetrics during labour. It may also be attached to ventilators or anaesthesia machines.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZR	Mixer, Breathing Gases, Anesthesia Inhalation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241465	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
No Device Sizes

Device Record Status

Public Device Record Key: f33eaa3b-6308-4a6d-ade9-845532f9e631
Public Version Date: October 22, 2024
Public Version Number: 1
DI Record Publish Date: October 14, 2024