AccessGUDID - DEVICE: Disposable MRI Kit with Check Valve (00616258007014)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable MRI Kit with Check Valve
Version or Model: SQK 65VA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SQK 65VA
Company Name: BAYER MEDICAL CARE INC.

Primary DI Number: 00616258007014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058716649 *Terms of Use

Device Description: Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50 (KIT,SYR/SPIKE/T,65ML FLS,MRI,BUR, MC,JA) (84192937)

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":	Yes
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?
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
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980417	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: dea9496a-45d9-45e5-bf39-d45cb167d00d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016