AccessGUDID - DEVICE: GEM FLOW NOW (00844735006377)

GUDID

Device Identifier (DI) Information

Brand Name: GEM FLOW NOW
Version or Model: 520002040011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GEM2770-FN
Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC

Primary DI Number: 00844735006377
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031284586 *Terms of Use

Device Description: Doppler Blood Flow Monitoring Device

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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?
10431	Electromagnetic blood flowmeter	A device using electromagnetic (EM) technology to provide a method of confirming and measuring the velocity of blood flow in vessels after coronary artery bypass, organ transplant, and other vascular reconstructive surgery. It uses an invasive technique that is performed with either a catheter inserted into a vessel or with a probe that surrounds a surgically exposed vessel without penetrating the vessel wall. Also known as an EM flowmeter.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYN	System, imaging, pulsed doppler, ultrasonic
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233394	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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Vessel Diameter: 2-4 Millimeter

Device Record Status

Public Device Record Key: f85ad5f5-124d-46ad-8ddc-5d8a7379a220
Public Version Date: November 29, 2024
Public Version Number: 1
DI Record Publish Date: November 21, 2024