FDA.reportPublic FDA data

K-Pump

Primary DI
00851314007052
Brand
K-Pump
Company
Innovative Med
Model
1000-0031
Catalog number
IM-1000-0031
Device description
K-Pump Infiltration Device. Surgical Infiltration/ Irrigation pump. Vibration free, quiet K-Pump is capable of infiltration rate from 20-1020 ml/ min. The K-Pump is controlled by pneumatic footswitch.
Published
2016-09-12
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
K991203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991203000IRRIGATION OR INFUSION PUMP K PUMPKmi Kolster Methods, Inc.1999-10-15FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851314007052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851314007052008513140070528513140070520851314007052

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration systemAn assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-458-1897benk@imibeauty.com

Regulatory Flags#

DUNS number
928308407
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851314007434EvulseLTM-Evu S 1500PG-MBOOST-15002021-06-02
00851314007465EvulseLTM-Evu S 1000PG-MBOOST-10002021-06-02
00851314007489EvulseLTM-Evu D 5-152021-06-02
00851314007472EvulseLTM-Evu S 500PG-MBOOST-5002021-06-02
00851314007519A.T.T.SIM-ATTS-C2-EXT2024-08-21
00851314007557A.T.T.S.IM-ATTS-C2LD-SS2025-01-15
00851314007502A.T.T.SIM-ATTS-CS-D2024-08-21
00851314007076A.T.T.S.ATTS-C2IM-ATTS-C22016-09-09
00851314007083A.T.T.SATTS-C75IM-ATTS-C752016-09-12
00851314007007Phantom2550-2IM-K2550-22016-09-19
00851314007014Phantom2540-1IM-K2540-12016-09-19
00851314007038Phantom2540-2IM-K2540-22016-09-19
00851314007045Phantom2550-1IM-K2550-12016-09-19
00851314007212KMI IMI Group19-00992017-07-18
00851314007410A.T.T.S SILO19-79002020-05-19
00851314007397A.T.T.SATTS-C2LD-DIM-ATTS-C2LD-D2020-03-06
00851314007403A.T.T.SATTS-C2-BDIM-ATTS-C2-BD2020-03-06
00851314007281A.T.T.S.IM-FI2019-02-04
00851314007205KMI IMI GROUPSFRT2017-07-03
10851314007431EvulseLTM-Evu S 15002021-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00856038001942IradimedIRADIMED CORP.FRN2026-10-08
10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533273BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533334BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
05060844770014SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770021SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770038SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770045SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770052SAFIRAMEDOVATE LIMITEDFRN2026-10-05
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
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
30815112020034Accessory 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