AccessGUDID - DEVICE: BOON (06938327900205)

GUDID

Device Identifier (DI) Information

Brand Name: BOON
Version or Model: 500105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 500105
Company Name: Shenzhen Boon Medical Supply Co., Ltd.

Primary DI Number: 06938327900205
Issuing Agency: GS1
Commercial Distribution End Date: April 26, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 529174252 *Terms of Use

Device Description: 500mm 1200PSI High Pressure Braided Line with Rotating Luer

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:	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?
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. 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 [?]
K151960	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: 09da1f61-993c-44f5-a340-579fabd3a4b9
Public Version Date: April 27, 2020
Public Version Number: 7
DI Record Publish Date: December 09, 2016