AccessGUDID - DEVICE: BT2000 Automated Manifold Kit (10841716100328)

GUDID

Device Identifier (DI) Information

Brand Name: BT2000 Automated Manifold Kit
Version or Model: 014613
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ACIST MEDICAL SYSTEMS, INC.

Primary DI Number: 10841716100328
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 BT2000 p/n 701279-004 Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer

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?
47258	Contrast medium injection system administration set	A collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.	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: aaa678db-089a-4e28-802b-d7b5246c5db9
Public Version Date: February 19, 2021
Public Version Number: 4
DI Record Publish Date: September 09, 2016