FDA.reportPublic FDA data

CADD

Primary DI
15019517149999
Brand
CADD
Company
ICU MEDICAL, INC.
Model
21-2120-0105-00
Published
2020-02-10
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111275000CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARESmiths Medical Asd, Inc.2013-02-01FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019517149999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951714999915019517149999

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose infusion pump, line-poweredA mains electricity (AC-powered) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers. The device has a typical flow range of 1 to 999 ml/hour and delivers solutions from a standard infusion bag or bottle of fluid. It typically has internal batteries that enable operation for a short period when no mains electricity is available (e.g., during transportation 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
10887709146966LifeShield Infusion Safety Software Suite - DFM17002-032026-10-23
10887709146973LifeShield Infusion Safety Software Suite - DLM17003-032026-10-23
10887709146980LifeShield Infusion Safety Software Suite - CDR17005-032026-10-23
10887709155050LifeShield Infusion Safety Software Suite17000-032026-10-23
10887709207230BivonaFU26JN50NSF167N2026-10-23
10887709207247BivonaFU26JN40NSF171N2026-10-23
10887709207254BivonaFT26JN35NGF170N2026-10-23
10887709207261BivonaFT26JN40NSA166N2026-10-23
10887709207278BivonaFU26JN55NGF168N2026-10-23
10887709207339BivonaFT26JN30NGE178N2026-10-23
10887709207346BivonaFT26JN35NGF174N2026-10-23
10887709207353BivonaFT26JN35NGF175N2026-10-23
10887709207360BivonaAT26JS30NGA177N2026-10-23
10887709207377BivonaAT26JS35NGA176N2026-10-23
10887709207100BivonaXU26JS40NGE159N2026-10-22
10887709207117BivonaFU26JN60NSC161N2026-10-22
10887709207124BivonaFU26JN50NGC162N2026-10-22
10887709207131BivonaHU26JS70NSC158N2026-10-22
10887709207148BivonaFT26JN40NGF157N2026-10-22
10887709207155BivonaFT26JN35NGE140N2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403532948BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-22
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
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20