FDA.reportPublic FDA data

HEPtrac®

Primary DI
00613994615633
Brand
HEPtrac®
Company
MEDTRONIC, INC.
Model
313-51
Device description
DEVICE 313-51 HEPTRAC ELEC QLT CNTRL CEM
Published
2016-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981815000HEPTRAC ELECTRONIC QUALITY CONTROLMedtronic Blood Management1998-07-30JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994615633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994615633006139946156336139946156330613994615633

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation timer IVDAn electronic device that is used to measure, indicate, and/or record the length of time taken for plasma or a whole blood sample to form a clot following the initiation of a reaction, typically as part of in vitro coagulation studies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-50 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11
00643169559981Euphora™EUP22525X2016-04-11

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Primary DI, Brand, Company table
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20763000558295RACTMEDTRONIC, INC.JPA2026-02-22
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04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
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10812747018531Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
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00842768018893Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
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04987562518654Automated Blood Coagulation Analyzer CS-5100SYSMEX CORPORATIONJPA2024-02-22
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04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONJPA2024-02-22
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