FDA.reportPublic FDA data

AIV

Primary DI
M745BX10468
Brand
AIV
Company
AMERICAN IV PRODUCTS, INC.
Model
BX10468
Catalog number
BX10468
Device description
Assembly Door 2 Baxter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K032789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032789000REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469American I.V. Products, Inc.2003-10-09FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M745BX10468PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pump, multichannelA mains electricity (AC-powered) multichannel device designed to facilitate continuous and/or intermittent intravenous (IV) delivery of two or more drugs and/or solutions, via infusion sets, via intravenous routes, but may be delivered via subcutaneous or arterial routes, with independent control of delivery through each channel. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers; has various flow ranges and rates and may use syringes, bags or bottles. It will typically have internal batteries to enable operation for a short period when no mains electricity is available (e.g., during transportation or a power outage).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.842Inch
Length8.325Inch
Width2.75Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
181184474
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M745FM10839AIVFM10839FM108392016-09-02
M745FM10840AIVFM10840FM108402016-09-02
M745FM10841AIVFM10841FM108412016-09-02
M745BX10469AIVBX10469BX104692016-09-24
M745BX12812AIVBX12812BX128122016-09-02
M745CBSP2AIVCBSP2CBSP22016-09-02
M745CB10586AIVCB10586CB105862016-09-02
M745CB10587AIVCB10587CB105872016-09-02
M745CB10588AIVCB10588CB105882016-09-02
M745CB10590AIVCB10590CB105902016-09-02
M745CB10639AIVCB10639CB106392016-09-02
M745CB10640AIVCB10640CB106402016-09-02
M745CB10641AIVCB10641CB106412016-09-02
M745CBHPHP1AIVCBHPHP1CBHPHP12016-09-02
M745CBHPN1AIVCBHPN1CBHPN12016-09-02
M745CBSP1AIVCBSP1CBSP12016-09-02
M745BC10746AIVBC10746BC107462016-09-02
M745BC10969AIVBC10969BC109692016-09-02
M745BC10747AIVBC10747BC107472016-09-02
M745BC10925AIVBC10925BC109252016-09-02

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