AccessGUDID - DEVICE: MEDRAD® Mark 7 Arterion Footswitch (00616258027241)

GUDID

Device Identifier (DI) Information

Brand Name: MEDRAD® Mark 7 Arterion Footswitch
Version or Model: ART 700 FS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ART 700 FS
Company Name: Bayer Medical Care Inc.

Primary DI Number: 00616258027241
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 049673973 *Terms of Use

Device Description: ASSY,FOOTSWITCH,ARTERION,LR,UDI (89234522)

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?
36336	Foot-switch, electrical	An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXT	Injector And Syringe, Angiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113133	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 5 and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 48 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad5c4d2a-d79b-46ee-81e4-e7a9d5766ffb
Public Version Date: May 14, 2024
Public Version Number: 1
DI Record Publish Date: May 06, 2024