FDA.reportPublic FDA data

Reprocess FloPatch

Primary DI
00627987360134
Brand
Reprocess FloPatch
Company
1929803 Ontario Corp
Model
FP120
Device description
Reprocessed FloPatch FP120
Published
2023-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627987360131PackageGS110In Commercial Distribution
20627987360138PackageGS14In Commercial Distribution
30627987360135PackageGS16In Commercial Distribution
00627987360134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062798736013110627987360131
2062798736013820627987360138
3062798736013530627987360135
00627987360134006279873601346279873601340627987360134

GMDN Terms#

Term, Definition table
TermDefinition
Invasive/noninvasive vascular ultrasound probeA 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.

Contacts#

Phone, Email table
PhoneEmail
289-998-2982regulatory@flosonicsmedical.com

Regulatory Flags#

DUNS number
204195374
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627987360110Hydrogel Adhesive StrapFP120-FOT01-0032022-06-17
00627987360141Dual Adhesive StrapFP120-FOT01-0052023-03-03
00627987360158Dual Adhesive StrapFP120-FOT01-0062025-06-23
00627987360127Acrylate Adhesive StrapFP120-FOT01-004 2022-06-17
00627987360103FloPatchFP1202020-09-22
10627987360155Dual Adhesive StrapFP120-FOT01-0062025-06-23
10627987360131Reprocess FloPatchFP1202023-05-08
10627987360148Dual Adhesive StrapFP120-FOT01-0052023-03-03
10627987360117Hydrogel Adhesive StrapFP120-FOT01-0032022-06-17
20627987360114FloPatchFP1202020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937029536CooperSurgical® Coopersurgical, Inc.DPW2026-04-10
00888937027815CooperSurgical® Coopersurgical, Inc.DPW2026-04-01
00888937027839CooperSurgical® Coopersurgical, Inc.DPW2026-04-01
00813079022664VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2025-11-27
00813079022671VascuChek Speaker DockREMINGTON MEDICAL, INC.DPW2025-11-27
00813079022688VascuChek KitREMINGTON MEDICAL, INC.DPW2025-11-27
00888937027822CooperSurgical® Coopersurgical, Inc.DPW2025-09-25
00627987360158Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
10627987360155Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
07070554102690Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
07070554103611Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
00813079022619VascuChek Surgical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022657VascuChek Clinical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
10813079022616VascuChek Surgical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022626VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022633VascuChek ChargerREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022640VascuChek KitREMINGTON MEDICAL, INC.DPW2024-08-23
10813079022654VascuChek Clinical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
07070554103444Medistim MiraQ Vascular SystemMedistim ASADPW2024-04-12
00817122020560VTI 8MHz TQI 2.0 Doppler TransceiverVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00817122020577Footswitch, MutingVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00817122020584Pole MountVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
10627987360131Reprocess FloPatch1929803 Ontario CorpDPW2023-05-08
00627987360141Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
10627987360148Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
00627987360110Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10627987360117Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
00627987360127Acrylate Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10080196734290MedlineMEDLINE INDUSTRIES, INC.DPW2022-03-04
07332834000066PeriFlux 6000Perimed ABDPW2021-10-20