FDA.reportPublic FDA data

Power Infuser

Primary DI
00847946021603
Brand
Power Infuser
Company
Zoll Medical Corporation
Model
1110-0051
Device description
PUMP CARTRIDGE, BLOOD, 10 PER CASE (IPN 0040-0051)
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090736000POWER INFUSER, MODEL M100B-3AZOLL Medical Corporation2009-05-20FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946021603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946021603008479460216038479460216030847946021603

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable professional automated external defibrillatorA portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is intended to be operated by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries that must be charged when not in use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055363428
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847946050740ZENIX1116-111075-21-USA-02026-09-25
00198843006454LTV18888-201-012026-09-18
00198843006492LTV18888-001-012026-09-18
00198843006515LTV18978-001-012026-09-18
00198843006539LTV18246-004-012026-09-18
00198843007352LTV18246-201-012026-09-18
001988430062703100B HFOV11744-850K-402026-08-26
001988430062943100A HFOV29028-003-402026-08-26
001988430063003100A HFOV29028-004-402026-08-26
001988430063243100B HFOV29028-016-402026-08-26
001988430063623100 HFOV11437-PMN-402026-08-26
00847946030926ZENIX8900-000421-012026-08-26
00198843003606Infant Flow™777010-402026-08-14
00198843003613Infant Flow™777012-402026-08-14
00198843003620Infant Flow™777014-402026-08-14
00198843003637Infant Flow™777016-402026-08-14
00198843003644Infant Flow™777018-402026-08-14
00198843003651Infant Flow™777020-402026-08-14
00198843003668Infant Flow™777022-402026-08-14
00198843003675Infant Flow™777024-402026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847946050740ZENIXZoll Medical CorporationMKJ2026-09-25
00847946030926ZENIXZoll Medical CorporationMKJ2026-08-26
00884838126275PHILIPS HeartStart SMARTPADS IIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126282PHILIPS HeartStart SMARTPADS IIIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126299FR2/FR2+ Adult Electrode PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126473PHILIPS HeartStart SMARTPADS IIIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
00884838126480PHILIPS FR/FR2/FR2+ Adult Electrode PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-26
10847946030954ZENIXZoll Medical CorporationMKJ2026-08-14
00884838126510HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-10
00884838126527HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-10
00884838126534HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-10
00884838126541Adult/Child Pre-Connect Defib PadPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2026-08-10
00198843006614ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006621ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006638ZENIXZoll Medical CorporationMKJ2026-07-21
00198843006645ZENIXZoll Medical CorporationMKJ2026-07-21
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
00815098021475Defibtech ARM XR Extended Suction Cup (package of 1)DEFIBTECH, L.L.C.MKJ2026-06-26
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00883873031902LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031933LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031957LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031971LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031995LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032015LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032145LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24