FDA.reportPublic FDA data

ICU Medical MedNet

Primary DI
10887709101811
Brand
ICU Medical MedNet
Company
ICU MEDICAL, INC.
Model
6.32.0
Catalog number
160379203
Device description
Mednet Software
Published
2019-10-09
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
PHCInfusion safety management software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHCInfusion Safety Management SoftwareGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141102000HOSPIRA MEDNET MEDICATION MANAGEMENT SUITEHospira, Inc.2014-07-08FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709101811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770910181110887709101811

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump medication-dosage application softwareA software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)241-4002TSC.Support@icumed.com

Regulatory Flags#

DUNS number
118380146
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04
10887709194929BivonaXT26FS50NSF019N2026-06-04
10887709194936BivonaFT26EN40NSF122S2026-06-04
10887709194943BivonaFT26EN40NSF122S2026-06-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860006582012TigerConnect Alarm ManagementCritical AlertPHC2026-05-29
10885403519475BD AlarisCAREFUSION 303, INC.PHC2025-12-23
00887709127227LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00887709127234LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00887709127241LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00811505030450Ivenix Infusion SystemFresenius Kabi AGPHC2024-12-06
20085412676610DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2024-08-23
10885403520020Alaris™ Guardrails™ Editor Software Kit, Model 8961CAREFUSION 303, INC.PHC2024-08-02
10885403519666BD Alaris™ System Manager 9601, SoftwareCAREFUSION 303, INC.PHC2024-06-19
00382905168017BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
00382905168024BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
60382905168033BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
10085412676613DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2024-04-22
00887709122802LifeShield Infusion Safety Software Suite - LifeShield DLMICU MEDICAL, INC.PHC2023-10-03
00887709122819LifeShield Infusion Safety Software Suite - LifeShield CDRICU MEDICAL, INC.PHC2023-10-03
00811505030443Ivenix Infusion SystemFresenius Kabi AGPHC2023-08-07
00811505030399Ivenix Infusion SystemFresenius Kabi AGPHC2023-07-19
00811050530399Ivenix Infusion SystemFresenius Kabi AGPHC2023-04-07
00085412676616DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2022-09-22
00811505030351Ivenix Infusion SystemFresenius Kabi AGPHC2022-09-07
10885403510472BD Alaris™ Infusion Adapter, SoftwareCAREFUSION 303, INC.PHC2022-08-12
10885403510489BD Alaris™ Calculation Services, SoftwareCAREFUSION 303, INC.PHC2022-06-09
04052682044106Vigilant Software SuiteFresenius Kabi AGPHC2022-05-20
15019517225471PharmGuardICU MEDICAL, INC.PHC2021-11-16
10885403896125Alaris™ Guardrails™ Editor Software Kit, Model 8961CAREFUSION 303, INC.PHC2021-10-08
10885403897535Alaris™ System Maintenance Software Kit, Model 8975CAREFUSION 303, INC.PHC2021-10-08
10885403960123AlarisCAREFUSION 303, INC.PHC2021-10-08
00811505030177Ivenix Infusion SystemFresenius Kabi AGPHC2021-06-25
00860006582005CommonPath EnterpriseCritical AlertPHC2021-04-22