FDA.reportPublic FDA data

BodyGuard 121 pump

Primary DI
B101100105TSA0
Brand
BodyGuard 121 pump
Company
CME AMERICA LLC
Model
100-105TSA
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
B101100105TSA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel general-purpose infusion pumpA 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).

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
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
B101100603XSA0BG 323 Pump100-603XSA2016-09-15

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