AccessGUDID - DEVICE: Medical Imaging Solutions International (06938327900038)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Imaging Solutions International
Version or Model: 200101-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100301
Company Name: Shenzhen Baoan Medical Supply Co., Ltd.

Primary DI Number: 06938327900038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529174252 *Terms of Use

Device Description: 2-65 mL Syringes 1-Large Spike, 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Angiographic syringe	A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Angiographic syringe

A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.

FDA Product Code

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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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37c2c929-2177-4904-a725-4efe3c2c6126
Public Version Date: July 06, 2018
Public Version Number: 5
DI Record Publish Date: November 11, 2016