Who else makes this device?

Name: FloProbe 3/8’’ x 3/8” (Non Sterile)
Brand: FloProbe 3/8’’ x 3/8” (Non Sterile)

Cardiovascular › MonitoringProbe, Blood-Flow, Extravascular

FloProbe 3/8’’ X 3/8” (Non Sterile)

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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DPT
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
RWD Life Science Co., Ltd.	Shenzhen	Guangdong	Manufacturer	4

Record

Regulatory record for FloProbe 3/8’’ x 3/8” (Non Sterile)
Listed by	Movair, Inc.
FDA product code	DPT
Device type	Probe, Blood-Flow, Extravascular
Device class	Class 2
Regulation	21 CFR 870.2120
510(k)	K963703
Record published	2016-07-12
Record revised	2025-02-24 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Distribution end date	2021-12-27

Catalogue Numbers

Catalogue numbers for FloProbe 3/8’’ x 3/8” (Non Sterile)
Catalogue number	Size	Per pack	Status
3080N		10	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medex	ICU Medical, Inc	138
Bio-Probe™	Medtronic, Inc.	21
Probe, Blood-Flow, Extravascular	Medtronic, Inc.	10
Moor Instruments Ltd	Moor Instruments Ltd.	3
Trillium™ Bio-Probe®	Medtronic, Inc.	2
Trillium™	Medtronic, Inc.	2
FloProbe 1/4’’ x 1/4″ (Non Sterile)	Movair, Inc.	1
FloProbe 1/4’’ x 1/4’’ (Sterile)	Movair, Inc.	1
I2P24 Doppler Probe	Deltex Medical Limited	1
I2S6 Doppler Probe	Deltex Medical Limited	1
moorFLPI-2 Review PC Software	Moor Instruments Ltd.	1
moorFLPI2- Measurement PC Software	Moor Instruments Ltd.	1

Showing 12 of 17. All products under Probe, Blood-Flow, Extravascular

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of FloProbe 3/8’’ x 3/8” (Non Sterile)
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
International Biophysics Corp.	510(k) number	2005-04-22	Not classified	Other	Complaints received regarding the device’s failure to zero out.	7,502	2006-07-18

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.