AccessGUDID - DEVICE: Coeur (M297732020)

GUDID

Device Identifier (DI) Information

Brand Name: Coeur
Version or Model: C853-3202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C853-3202
Company Name: COEUR, INC.

Primary DI Number: M297732020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132515441 *Terms of Use

Device Description: 200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60" Y-line, 1 Contrast Spike, and 1-Saline Spike

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?
15286	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXT	Injector And Syringe, Angiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170431	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
Special Storage Condition, Specify: Keep product in clean, dry location. Avoid direct rays, heat and high humidity, and ultraviolet rays such as a germicidal light.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 400 Milliliter

Device Record Status

Public Device Record Key: 0c069052-6f29-4a58-b8d5-6a51d77a4bc2
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 11, 2019