Medfusion

Primary DI
10610586043574
Brand
Medfusion
Company
ICU MEDICAL, INC.
Model
4000-0105-78
Published
2016-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FRNPump, infusion
MRZACCESSORIES, PUMP, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111386000MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)Smiths Medical MD, Inc.2011-08-29FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610586043574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061058604357410610586043574

GMDN Terms#

Term, Definition table
TermDefinition
Bedside syringe pumpA mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
10610586043307MedfusionICU MEDICAL, INC.MRZ2022-03-29
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517154986CADDICU MEDICAL, INC.MRZ2020-02-28
15019517155006CADDICU MEDICAL, INC.MRZ2020-02-28
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517165753CADDICU MEDICAL, INC.MRZ2019-12-30
15019517154290CADDICU MEDICAL, INC.MRZ2019-12-05
15019517154887CADDICU MEDICAL, INC.MRZ2019-12-05
15019517154894CADDICU MEDICAL, INC.MRZ2019-12-05
15019517154993CADDICU MEDICAL, INC.MRZ2019-12-05
15019517155020CADDICU MEDICAL, INC.MRZ2019-12-05
15019517151107PharmGuardICU MEDICAL, INC.MRZ2019-12-02
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517154306MEDFUSIONICU MEDICAL, INC.MRZ2019-09-18
15019517154313MEDFUSIONICU MEDICAL, INC.MRZ2019-09-18
15019517154320MEDFUSIONICU MEDICAL, INC.MRZ2019-09-18
15019517130928MedfusionICU MEDICAL, INC.MRZ2019-03-08
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
10887787007265SapphireICU Medical, Inc.MRZ2018-06-04
10887787007272SapphireICU Medical, Inc.MRZ2018-06-04
10887787007302SapphireICU Medical, Inc.MRZ2018-06-04
10887787007319SapphireICU Medical, Inc.MRZ2018-06-04
10887787007357SapphireICU Medical, Inc.MRZ2018-06-04
10887787007364SapphireICU Medical, Inc.MRZ2018-06-04
10887787007395SapphireICU Medical, Inc.MRZ2018-06-04