AccessGUDID - DEVICE: AngioTouch® Kit (10841716101936)

GUDID

Device Identifier (DI) Information

Brand Name: AngioTouch® Kit
Version or Model: 014644
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ACIST MEDICAL SYSTEMS, INC.

Primary DI Number: 10841716101936
Issuing Agency: GS1
Commercial Distribution End Date: February 27, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 926684994 *Terms of Use

Device Description: Model AT P54, p/n 700608-054 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

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:	Yes
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?
47260	Contrast medium injection system hand controller kit	A collection of non-powered devices designed to be used and interact with a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of a high pressure line, a high pressure stopcock, and a hand-held manual controller used to stop and start the contrast medium injection system instantaneously. It is typically made of plastic materials and may have one control for dispensing the contrast medium and a second for dispensing the saline. This is a single-use 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 [?]
Premarket Submission Number Not Available/Not Released

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: a01ee8ce-eb32-467e-80e6-41d5139fd2c3
Public Version Date: September 16, 2022
Public Version Number: 3
DI Record Publish Date: March 02, 2018