FDA.reportPublic FDA data

PharmGuard

Primary DI
15019517151107
Brand
PharmGuard
Company
ICU MEDICAL, INC.
Model
22-4075-0301-51
Published
2019-12-02
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
15019517151107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951715110715019517151107

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
10887709206905BivonaFU26JN40NSC136N2026-10-20
10887709206912BivonaFT26JN35NSE138N2026-10-20
10887709206936BivonaFT26JN60NSF126N2026-10-20
10887709206950BivonaFU26JN30NSE134N2026-10-20
10887709206967BivonaFU26JN35NSE135N2026-10-20
10887709206974BivonaFU26JN30NSF137N2026-10-20
10887709206981BivonaFT26JN40NSE142N2026-10-20
10887709206998BivonaFT26JN35NSE143N2026-10-20
10887709207001BivonaSU26JN50NSB144N2026-10-20
10887709206776BivonaFT26JN55NGC127N2026-10-19
10887709206783BivonaXT26JS60NGC132N2026-10-19
10887709206813BivonaXT26JS40NGF130N2026-10-19
10887709206844BivonaFT26JN30NGF129N2026-10-19
10887709206851BivonaFT26JN60NSC131N2026-10-19
10887709206868BivonaFU26JN45NGA115N2026-10-19
10887709206875BivonaFT26JN35NGF133N2026-10-19
10887709206882BivonaSA26JN70NSC097N2026-10-19
10887709206899BivonaFU26HN40NGF206S2026-10-19
10887709206646BivonaSA26JN95NSC113N2026-10-16
10887709206653BivonaHA26JS85NSC114N2026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B5530701001OTC0Health OptimizerWELLDOC, INC.MRZ2026-10-14
B5530702001OTC0Health OptimizerWELLDOC, INC.MRZ2026-10-14
B5530703001OTC0Health OptimizerWELLDOC, INC.MRZ2026-10-14
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
04046955582969Perfusor®B. BRAUN MEDICAL INC.MRZ2026-06-07
B553202291OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202292OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202293OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
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
B553BYRAMCONNECT100ByramConnectWELLDOC, INC.MRZ2021-09-27