FDA.reportPublic FDA data

HMS PLUS

Primary DI
00681490512084
Brand
HMS PLUS
Company
MEDTRONIC, INC.
Model
R30514
Device description
INSTRUMENT R30514 HMS PLUS RECON
Published
2016-04-29
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
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
00681490512084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490512084006814905120846814905120840681490512084

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
Special Storage Condition, Specify00Keep Dry
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius49 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
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

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
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