FDA.reportPublic FDA data

Sapphire Multi-Pump Mounting System Power Supply – US

Primary DI
17290109153930
Brand
Sapphire Multi-Pump Mounting System Power Supply – US
Company
EITAN MEDICAL LTD
Model
17000-020-0008
Catalog number
17000-020-0008
Published
2022-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192860000Sapphire Infusion Pump, Sapphire administration setsQ Core Medical , Ltd.2020-11-19FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109153919Direct MarkingGS10
27290109153913PackageGS14In Commercial Distribution
17290109153930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109153919072901091539197290109153919
2729010915391327290109153913
1729010915393017290109153930

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pole multi-outlet holderA mains electricity (AC-powered) device used with an intravenous (IV) pole (usually of the floor-standing type) and designed to provide multiple electrical outlet sockets so that an electrical source is made available when two or more infusion pumps are mounted into the retaining slots provided. This device will fit onto a standard IV pole and is intended to accept the mounting of a number of infusion pumps, keeping them safely fastened to the pole in an organized manner.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
533108028
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290109156009AP504-0112000-000-00452026-05-07
17290109156016AP433-0112000-000-00442026-05-05
17290109155972AV1029-01 Avoset Microbore set 12222-000-102912222-000-1029AV1029-012026-04-14
17290109155996AV1027-01 Avoset Microbore set 12222-000-102712222-000-1027AV1027-012026-04-14
17290109152704AV1016-01 Avoset 250mL Medication Reservoir Pouch12222-000-1016AV1016-012025-08-31
17290109152766AV1010-01 Minibore Extension Set12222-000-10102025-05-29
27290109152640AV1010-01 Minibore Extension Set12222-000-10102025-05-29
17290109152742Avoset Kit - US17000-036-00042025-03-05
17290109155217AP209-0112003-000-10272025-03-05
27290109152749Avoset Kit - US17000-036-00042025-03-05
27290109155214AP209-0112003-000-10272025-03-05
17290109155873AP414-0112003-000-00212025-02-10
27290109155870AP414-0112003-000-00212025-02-10
17290109152674AV1017-01 Avoset 50ML Medication Reservoir12222-000-10172025-02-03
27290109152688AV1017-01 Avoset 50ML Medication Reservoir12222-000-10172025-02-03
17290109155880AP434-0112000-000-003012000-000-00302025-01-27
27290109155887AP434-0112000-000-003012000-000-00302025-01-27
17290109155286AP426-0112003-000-00252024-11-30
07290109155296Sapphire PCA Lockbox 500mL Label 15062-131-00102024-11-29
27290109155283AP426-0112003-000-00252024-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955739721SPACEB. BRAUN MEDICAL INC.MRZ2026-04-11
B553202291OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202292OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202293OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
00085412718378Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
00085412947914Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
00840365902096InvenioGri-Alleset, Inc.MRZ2025-03-12
10840365902093InvenioGRI Medical & Electronic Technology Co., Ltd.MRZ2025-03-12
07290109155296Sapphire PCA Lockbox 500mL Label EITAN MEDICAL LTDMRZ2024-11-29
15019517375244CADDICU MEDICAL, INC.MRZ2024-10-14
1729010915261250/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
17290109152629Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
2729010915261950/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
27290109152626Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
B553202191OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202192OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202193OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202091OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
B553202092OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
17290109151653PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
27290109151650PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
17290109154104Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
27290109154101Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
B553202093OTC0Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER190Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER180Health OptimizerWELLDOC, INC.MRZ2023-11-17
00850025535502UTC 3ml Medication CartridgeGilero, LLCMRZ2023-09-25
17290109154708Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05
27290109154705Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05