FDA.reportPublic FDA data

Plum Duo Infusion System

Primary DI
M335400021
Brand
Plum Duo Infusion System
Company
ICU MEDICAL, INC.
Model
1.1
Catalog number
400020401
Device description
Plum Duo Dual Channel Infusion System
Published
2023-10-13
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
FRNPump, infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223607000Plum Duo™ Infusion SystemIcu Medical, Inc.2023-08-24FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M335400021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pump, multichannelAn electrically-powered, non-ambulatory (bedside) device designed to facilitate the simultaneous, accurate, and consistent administration of multiple drugs/solutions (multichannel) from a standard infusion bag or bottle, via intravenous, subcutaneous, arterial, epidural, and intracavital routes, using a dedicated infusion set. It is not dedicated to a specific treatment type and is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

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
10887709206172BivonaFU26JN30NSF074N2026-10-12
10887709206189BivonaFU26JN35NSF073N2026-10-12
10887709206196BivonaFT26JN40NGF076N2026-10-12
10887709206202BivonaST26JN55NSC078N2026-10-12
10887709206219BivonaHA26JS60NSB077N2026-10-12
10887709206226BivonaFT26JN60NSC079N2026-10-12
10887709206233BivonaFU26JN35NSF072N2026-10-12
10887709206240BivonaHT26JS70NSC080N2026-10-12
10887709206257BivonaFT26JN35NSE084N2026-10-12
10887709206264BivonaFT26JN55NGF081N2026-10-12
10887709206271BivonaFT26JN40NGF082N2026-10-12
10887709206288BivonaFT26JN60NGC083N2026-10-12
10887709206103BivonaFU26JN40NGE065N2026-10-09
10887709206110BivonaFT26JN50NGF066N2026-10-09
10887709206127BivonaSU26JN50NSC067N2026-10-09
10887709206134BivonaHU26JS60NSC069N2026-10-09
10887709206141BivonaHU26JS70NSC068N2026-10-09
10887709206158BivonaFU26JN45NSA070N2026-10-09
10887709206165BivonaFT26JN35NSE071N2026-10-09
10887709206011BivonaXU26JS35NGF064N2026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
30815112020614Accessory 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