FDA.reportPublic FDA data

PharmGuard

Primary DI
15019517157888
Brand
PharmGuard
Company
ICU MEDICAL, INC.
Model
22-0117-0201-25
Published
2019-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K141193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141193000MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0Smiths Medical Asd, Inc.2014-07-25PHC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019517157888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951715788815019517157888

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

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

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