NA

Primary DI
20613994697268
Brand
NA
Company
MEDTRONIC, INC.
Model
304-11POR
Device description
CRTG 304-11POR PORC HMS BLK 5L INT 9PK
Published
2016-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOXANALYZER, HEPARIN, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOXAnalyzer, Heparin, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922031000HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROLMedtronic Hemotec, Inc.1992-07-21JOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994697268PrimaryGS10
00613994697264Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399469726820613994697268
00613994697264006139946972646139946972640613994697264

GMDN Terms#

Term, Definition table
TermDefinition
Heparin anti-Xa IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Refrigerated 2°C-10°C
Special Storage Condition, Specify00Room Temperature 10°C-25°C

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
9
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20643169713158NAMEDTRONIC, INC.JOX2023-04-08
20643169713165NAMEDTRONIC, INC.JOX2023-04-08
20643169713172NAMEDTRONIC, INC.JOX2023-04-08
20643169713189NAMEDTRONIC, INC.JOX2023-04-08
20643169713196NAMEDTRONIC, INC.JOX2023-04-08
20643169713202NAMEDTRONIC, INC.JOX2023-04-08
20643169713219NAMEDTRONIC, INC.JOX2023-04-08
20643169713226N/AMEDTRONIC, INC.JOX2023-04-08
20643169713233NAMEDTRONIC, INC.JOX2023-04-08
20643169713240NAMEDTRONIC, INC.JOX2023-04-08
00643169713147NAMEDTRONIC, INC.JOX2023-04-08
00643169713154NAMEDTRONIC, INC.JOX2023-04-08
00643169713161NAMEDTRONIC, INC.JOX2023-04-08
00643169713178NAMEDTRONIC, INC.JOX2023-04-08
00643169713185NAMEDTRONIC, INC.JOX2023-04-08
00643169713192NAMEDTRONIC, INC.JOX2023-04-08
00643169713208NAMEDTRONIC, INC.JOX2023-04-08
00643169713215NAMEDTRONIC, INC.JOX2023-04-08
00643169713222N/AMEDTRONIC, INC.JOX2023-04-08
00643169713239NAMEDTRONIC, INC.JOX2023-04-08
00643169713246NAMEDTRONIC, INC.JOX2023-04-08
20643169713257N/AMEDTRONIC, INC.JOX2021-11-12
20763000014753N/AMEDTRONIC, INC.JOX2021-11-12
20763000014760N/AMEDTRONIC, INC.JOX2021-11-12
20763000014777N/AMEDTRONIC, INC.JOX2021-11-12
20763000014784N/AMEDTRONIC, INC.JOX2021-11-12
20763000014791N/AMEDTRONIC, INC.JOX2021-11-12
00643169713253N/AMEDTRONIC, INC.JOX2021-11-12
00763000014759N/AMEDTRONIC, INC.JOX2021-11-12