FDA.reportPublic FDA data

MD Resource

Primary DI
00859898006423
Brand
MD Resource
Company
MEDICAL DEVICE RESOURCE CORPORATION
Model
K Pump
Catalog number
K Pump
Device description
K Pump Infiltration Pump
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012044000BI-PHASIC INFILTRATORReliance Medical Corp.2001-08-28FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859898006423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859898006423008598980064238598980064230859898006423

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose infusion pump, line-poweredA mains electricity (AC-powered) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers. The device has a typical flow range of 1 to 999 ml/hour and delivers solutions from a standard infusion bag or bottle of fluid. It typically has internal batteries that enable operation for a short period when no mains electricity is available (e.g., during transportation or a power outage).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
510-732-9950sales@mdresource.com

Regulatory Flags#

DUNS number
126830020
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859898006249MD ResourceAV1200DAV1200D2016-09-08
00859898006386MD ResourceLS7020LS70202016-10-31
00859898006409MD ResourceAV2000DAV2000D2016-09-08
00859898006096MD ResourceLS7030LS70302016-08-30
00859898006430MD ResourceBPIBPI2016-09-08
00859898006003MD ResourceLS7010LS70102016-08-30
00859898006119MD ResourceLS7012LS70122016-08-30
60859898006241MD ResourceAV1200DAV1200D2016-09-08
10859898006383MD ResourceLS7020LS70202016-10-31
70859898006408MD ResourceAV2000DAV2000D2016-09-08
00859898006140MD ResourceLS7010LS70102016-08-30
00859898006133MD ResourceLS7012LS70122016-08-30
00859898006508MD ResourceFL3000M2019-09-11
00859898006492MD ResourceFL30002019-09-11
10859898006505MD ResourceFL3000M2019-09-11
00859898006256MD ResourceLS2-DPLS2-DP2016-09-23
00859898006379MD ResourceLS2-DLSLS2-DLS2016-09-23
00859898006416MD ResourceLS2LS22016-09-08
00859898006454MD ResourceRM2000RM20002016-09-13
00859898006027MD ResourceAFTDAFTD2016-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18
20763000273334MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
20763000273358MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
70643169771481MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2018-05-31
08050616611635APO-GO Syringe reservoirCANE' SPAFRN2018-05-28
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTDFRN2018-02-22
09350902001614Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001690Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001720Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001751Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18