AccessGUDID - DEVICE: Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box (10817122020253)

GUDID

Device Identifier (DI) Information

Brand Name: Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box
Version or Model: 128361
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 128361
Company Name: VASCULAR TECHNOLOGY, INCORPORATED

Primary DI Number: 10817122020253
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2025
Device Count: 4
Labeler D-U-N-S® Number*: 161989343 *Terms of Use

Device Description: Part Number 128361, Ultrasonic Blood Flow Detector Straight Probe, Box

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?
62211	Invasive/noninvasive vascular ultrasound probe	A hand-operated component of a vascular ultrasound system intended to be used to measure the flow of blood both invasively by being applied to the outside of an isolated blood vessel perioperatively, and noninvasively by measuring flow in underlying vasculature from the body surface pre-/post-operatively, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPW	FLOWMETER, BLOOD, CARDIOVASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082870	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ee95f6d-f047-4014-9566-a7496a0bbf5a
Public Version Date: June 02, 2025
Public Version Number: 6
DI Record Publish Date: September 20, 2016