PharmGuard

Primary DI
15019517177374
Brand
PharmGuard
Company
ICU MEDICAL, INC.
Model
22-0117-0202-25
Published
2020-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
15019517177374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951717737415019517177374

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
04046955582969Perfusor®B. BRAUN MEDICAL INC.MRZ2026-06-07
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
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
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
10887787007401SapphireICU Medical, Inc.MRZ2018-06-04