FDA.reportPublic FDA data

N/A

Primary DI
20763000014760
Brand
N/A
Company
MEDTRONIC, INC.
Model
306-02POR
Device description
CONTROL 306-02POR PORC HMS TAN/SIL 10BX
Published
2021-11-12
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
20763000014760PrimaryGS10
00763000014766Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300001476020763000014760
00763000014766007630000147667630000147660763000014766

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Lyophilized heparin assay controls must be refrigerated (2°C to 10°C [35.6°F to 50°F]) until use.
Special Storage Condition, Specify00Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C [35.6°F to 77°F])
Special Storage Condition, Specify00Temperature Limit 2°C-10°C

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000354466Symplicity Spyral™RDN0162023-11-30
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02

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
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
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