DEVICE: Disposable MRI Kit with Check Valve (00616258024301)

Device Identifier (DI) Information

Disposable MRI Kit with Check Valve
SQK 65VS
In Commercial Distribution
SQK 65VS
Bayer Medical Care Inc.
00616258024301
GS1
December 31, 9999
1
049673973 *Terms of Use
SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LNH System, Nuclear Magnetic Resonance Imaging
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K980417 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

813f4bb1-7ed2-405e-a230-3d1449ec1784
May 14, 2024
1
May 06, 2024
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
40616258024309 50 00616258024301 9999-12-31 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1 800-633-7231
ricustomercomplaints@bayer.com
CLOSE