AccessGUDID - DEVICE: FloProbe 3/8" x 3/8” (Sterile) (00814321020186)

GUDID

Device Identifier (DI) Information

Brand Name: FloProbe 3/8" x 3/8” (Sterile)
Version or Model: 3080S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Movair, Inc.

Primary DI Number: 00814321020186
Issuing Agency: GS1
Commercial Distribution End Date: December 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 788403103 *Terms of Use

Device Description: The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.

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:	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
DPT	Probe, Blood-Flow, Extravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963703	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b763200-e9d9-49f7-ad66-59be492c8b74
Public Version Date: February 24, 2025
Public Version Number: 5
DI Record Publish Date: June 18, 2016