FDA.reportPublic FDA data

BodyGuard 575 ColorVision Pump

Primary DI
B101100620XCV0
Brand
BodyGuard 575 ColorVision Pump
Company
CME AMERICA LLC
Model
100-620XCV
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion
MEAPump, Infusion, Pca

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
MEAPump, Infusion, PcaGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042696000BODYGUARD INFUSION PUMP SYSTEMCaesarea Medical Electronics , Ltd.2005-03-11FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B101100620XCV0PrimaryHIBCC0

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-13 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-936-4945xx@xx.xx

Regulatory Flags#

DUNS number
002125419
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B101100100POBSC0T34 Syringe Pump System100-100POBSC2016-09-15
B101100100PSA0T34 Syringe Pump System100-100PSA2016-09-15
B101100105TSA0BodyGuard 121 pump100-105TSA2016-09-15
B101100105TSAR0Refurbished BodyGuard 121 Twins Pump100-105TSAR2016-09-15
B101100908PTS0BodyGuard® 121 Twins Pump100-908PTS2016-09-15
B101100908PTSR0Refurbished BodyGuard® 121 Twins Pump100-908PTSR2016-09-15
B101150317TS0BodyGuard® 121 Pole Mount Charger with DC150-317TS2016-09-16
B101150317TSR0Refurbished BodyGuard® 121 Pole Mount Charger with DC150-317TSR2016-09-16
B101100500PXE0Manufacturing Kit CMExpress® Pump100-500PXE2020-07-08
B101100500PX0CMExpress® Pump100-500PX2016-09-15
B101100500PXA0CMExpress® Pump100-500PXA2016-09-15
B101100500PXR0Refurbished CMExpress® Pump100-500PXR2016-09-15
B101100500XA0CMExpress® Pump100-500XA2016-09-15
B101100500XAR0Refurbished CMExpress® Pump100-500XAR2016-09-15
B101100510PXSI0BG 323 Pump System100-510PXSI2016-09-15
B101100510PXSIR0Refurbished BG 323 Pump System100-510PXSIR2016-09-15
B101100516PXS0BG 323 Pump System100-516PXS2016-09-15
B101100516PXSR0Refurbished BG 323 Pump System100-516PXSR2016-09-15
B101100517PXS0BG 323 Pump System100-517PXS2016-09-15
B101100517PXSR0Refurbished BG 323 Pump System100-517PXSR2016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
15019517155006CADDICU MEDICAL, INC.MEA2020-02-28
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517165753CADDICU MEDICAL, INC.MEA2019-12-30
15019517171969CADDICU MEDICAL, INC.MEA2019-12-30
15019517154887CADDICU MEDICAL, INC.MEA2019-12-05
15019517154993CADDICU MEDICAL, INC.MEA2019-12-05
15019517155013CADDICU MEDICAL, INC.MEA2019-12-05
15019517155020CADDICU MEDICAL, INC.MEA2019-12-05
15019517173864CADDICU MEDICAL, INC.MEA2019-12-05
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18
20763000273334MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
20763000273358MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
M3352083704021Lifecare PCAICU MEDICAL, INC.MEA2018-12-13
08050616611635APO-GO Syringe reservoirCANE' SPAFRN2018-05-28
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTDFRN2018-02-22