FDA.reportPublic FDA data

N/A

Primary DI
20643169713226
Brand
N/A
Company
MEDTRONIC, INC.
Model
304-09POR
Device description
CRTG 304-09POR PORC HMS WHT 5L INT 9PK
Published
2023-04-08
Public version status
New
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
K894317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894317000HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.Hemotec, Inc.1989-09-05JOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20643169713226PrimaryGS10
00643169713222Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064316971322620643169713226
00643169713222006431697132226431697132220643169713222

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

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
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20643169713141NAMEDTRONIC, INC.JOX2023-04-08
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
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
00763000014766N/AMEDTRONIC, INC.JOX2021-11-12