FDA.reportPublic FDA data

Wells Johnson HVP System

Primary DI
B458206200000
Brand
Wells Johnson HVP System
Company
The Wells Johnson Company
Model
20620000
Catalog number
20-6200-00
Device description
Wells Johnson HVP System (High Volume Precision), 100-264VAC, 50/60Hz, 24W
Published
2023-07-14
Public version status
New
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
K991437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991437000WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00Wells Johnson Co.1999-08-30FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B458206200000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pump, single-channelAn electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It 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) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048931625
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B458205186000Small Volume Harvesting Canister250ml20-5186-002025-02-05
B458205187000Small Volume Harvesting Canister500ml20-5187-002025-02-05
B458205173000High Volume Harvesting Canister1000ml (1L)20-5173-002023-07-14
B458205174000High Volume Harvesting Canister2000ml (2L)20-5174-002023-07-14
B458205175000High Volume Harvesting Canister3000ml (3L)20-5175-002023-07-14
B458205997000HVP Cart2059970020-5997-002026-04-20
B458205998000Wells Johnson Hymen Cart2059980020-5998-002026-04-20
B458205061000Wells Johnson Elite Infiltrator/Aspirator2050610020-5061-002023-11-20
B458205066000Wells Johnson Elite Infiltrator/Aspirator2050660020-5066-002023-11-20
B458201300000DEL VECCHIO RE-INJECTION, 14g2013000020-1300-002025-09-10
B458201826020TABLE, VTS, 240VAC2018260220-1826-022025-09-08
B458201550000C-MAX2015500020-1550-002025-09-05
B458201826000TABLE, VTS, 240VAC2018260020-1826-002023-08-31
B4582013390003-PORT RADIAL VT2013390020-1339-002023-07-19
B458201314000"DEL VECCHIO 12-HOLE, 4MM, 1"" BLUE ERGO"2013140020-1314-002025-07-28
B458208300000HVC3™ 2083000020-8300-002024-10-08
B458205188000High Volume Harvesting Canister5000ml (5L)20-5188-002023-07-14
B458201825000TABLE, VTS, 120VAC2018250020-1825-002023-08-31
B458201266000FISCHER (ALOUF)2012660020-1266-002024-04-19
B458201360000INFILTRATION CANNULA SET, WIS (2)2013600020-1360-002024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856038001942IradimedIRADIMED CORP.FRN2026-10-08
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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