AccessGUDID - DEVICE: MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 50cm (20in) (00616258006963)

GUDID

Device Identifier (DI) Information

Brand Name: MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 50cm (20in)
Version or Model: TAG C50 HPCT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TAG C50 HPCT
Company Name: BAYER MEDICAL CARE INC.

Primary DI Number: 00616258006963
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058716649 *Terms of Use

Device Description: Twist & Go HPCT, CoEx, 20'' (ANGIO - ART, HPCT, TWIST & GO, CO-EX, 20") (60766825)

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?
44685	Radiographic procedure tubing	A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPK	Tubing, Fluid Delivery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131517	000

Device Exempt from Premarket Submission: No 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: 953f21bf-2ff7-474b-9864-88a4811e31d4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016