AccessGUDID - DEVICE: Smart Monitor (00815241020829)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Monitor
Version or Model: SMART
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OSPREY MEDICAL INC.

Primary DI Number: 00815241020829
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938215568 *Terms of Use

Device Description: The device consists of a Smart Monitor to be used with the DyeVert or DyeTect systems during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
Prescription Use (Rx):	No
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?
36310	Contrast medium conservation system	An assembly of electromechanical devices that serves a contrast medium injector system by controlling the amount of contrast agent supplied to the syringe/injector portion of the contrast medium injector system. It is designed to optimise the use of injectible contrast agents in order to prevent unnecessary waste of contrast media during and/or between patient procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXT	Injector And Syringe, Angiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: d54c8101-a6f0-4de9-ada9-d547d8cd75b7
Public Version Date: November 06, 2019
Public Version Number: 1
DI Record Publish Date: October 29, 2019