AccessGUDID - DEVICE: GEM FLOW COUPLER MONITOR (00844735006148)

GUDID

Device Identifier (DI) Information

Brand Name: GEM FLOW COUPLER MONITOR
Version or Model: GEM1020M-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 515600000011
Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC

Primary DI Number: 00844735006148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031284586 *Terms of Use

Device Description: The Flow COUPLER Monitor is a pulsed Doppler ultrasound system designed to detect vessel blood flow and confirm vessel patency intra and post-operatively at the anastomotic site as needed up to 7 days.

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:	No
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?
61236	Vascular ultrasound system control unit	A mains electricity (AC-powered) external device, which may include internal rechargeable batteries, intended to be used to indicate (visually and/or sonically) blood flow in a peripheral blood vessel, through connection to a dedicated probe/catheter (not included), using ultrasound/Doppler/transit time technology. It may be intended to locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) or to monitor blood flow in association with microvascular surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPW	FLOWMETER, BLOOD, CARDIOVASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191252	000

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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0b02bc7-559f-4eff-b7ab-050ebdba3488
Public Version Date: July 27, 2023
Public Version Number: 6
DI Record Publish Date: September 30, 2019