FDA.reportPublic FDA data

GEM FLOW COUPLER AC POWER SUPPLY KIT, US

Primary DI
00844735006155
Brand
GEM FLOW COUPLER AC POWER SUPPLY KIT, US
Company
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Model
GEM1020PS-2
Catalog number
515600001011
Device description
An insulated electrical cord (one piece) designed to connect the Flow COUPLER Monitor to a mains electricity supply socket. It has four adapters to accommodate voltage specific to the EU, UK, US, and Australia.
Published
2019-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFLOWMETER, BLOOD, CARDIOVASCULAR

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191252000Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.2019-07-09MVR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844735006155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844735006155008447350061558447350061550844735006155

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)510-3318MEDINFO_MEDPRODUCTS@BAXTER.COM

Regulatory Flags#

DUNS number
031284586
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844735006230GEM BIOVER Microvascular ClampTKFV-1TKFV-12022-04-19
00844735006247GEM BIOVER Microvascular ClampTKSV-1TKSV-12022-04-19
00844735006254GEM BIOVER Microvascular ClampTKMV-1TKMV-12022-04-19
00844735006261GEM BIOVER Microvascular ClampTKLV-1TKLV-12022-04-19
00844735006278GEM BIOVER Microvascular ClampTKS-1TKS-12022-04-19
00844735006285GEM BIOVER Microvascular ClampTKM-1TKM-12022-04-19
00844735006292GEM BIOVER Microvascular ClampTKL-1TKL-12022-04-19
00844735006308GEM BIOVER Microvascular ClampTKFV-2TKFV-22022-04-19
00844735006315GEM BIOVER Microvascular ClampTKSV-2TKSV-22022-04-19
00844735006322GEM BIOVER Microvascular ClampTKMV-2TKMV-22022-04-19
00844735006339GEM BIOVER Microvascular ClampTKLV-2TKLV-22022-04-19
00844735006346GEM BIOVER Microvascular ClampTKS-2TKS-22022-04-19
00844735006353GEM BIOVER Microvascular ClampTKM-2TKM-22022-04-19
00844735006360GEM BIOVER Microvascular ClampTKL-2TKL-22022-04-19
00844735002607GEM Microvascular Anastomotic COUPLERGEM27505111001000602015-10-08
00844735002621GEM Microvascular Anastomotic COUPLERGEM27515111001500602015-10-08
00844735002645GEM Microvascular Anastomotic COUPLERGEM27525111002000602015-10-08
00844735002669GEM Microvascular Anastomotic COUPLERGEM27535111002500602015-10-08
00844735002683GEM Microvascular Anastomotic COUPLERGEM27545111003000602015-10-08
00844735002706GEM Microvascular Anastomotic COUPLERGEM27555121003500602015-10-08

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Primary DI, Brand, Company table
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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
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00817122020584Pole MountVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00627987360134Reprocess FloPatch1929803 Ontario CorpDPW2023-05-08
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
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