FDA.reportPublic FDA data

SentinelPLUS®

Primary DI
00896406002591
Brand
SentinelPLUS®
Company
ALCOR SCIENTIFIC INC.
Model
S-3000-IU
Device description
SentinelPLUS®, Enteral Feeding Pump
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LZHPump, Infusion, Enteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZHPump, Infusion, EnteralGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011587000SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMPEntracon Corp.2001-06-01LZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896406002591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896406002591008964060025918964060025910896406002591

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding pumpA mains electricity (AC-powered) device designed to create pressure to accurately control the rates of flow of nutrient fluids directly into the stomach, duodenum, or jejunum, via enteral tubing, in patients who are unable or unwilling to consume adequate nutrients.

Regulatory Flags#

DUNS number
884153748
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850028040041iSED Elite112-00222112-002222023-11-03
00896406002508iSED112-00101112-001012020-01-09
00896406002874miniiSED112-01017112-010172020-01-09
00896406002614Alcor SENTINELplusE-1200SPE-1200SP2017-05-05
00896406002621Alcor SENTINELplusEN-1004SPEN-1004SP2017-05-05
00896406002638Alcor SENTINELplusEN-1203SPEN-1203SP2017-05-05
00896406002645Alcor SENTINELplusE-1200SPE-1200SP2017-03-22
00896406002652Alcor SENTINELplusE-500SPE-500SP2017-05-05
00896406002669Alcor SENTINELplusEN-500SPEN-500SP2017-05-05
00896406002683Alcor SENTINELplusEN-1200SPEN-1200SP2017-05-05
00896406002690Alcor SENTINELplusE-500SPE-500SP2017-03-23
00896406002706Alcor SENTINELplusE-1203SPE-1203SP2017-03-23
00896406002713Alcor SENTINELplusE-1004SPE-1004SP2017-05-05
10896406002628Alcor SENTINELplusEN-1004SPEN-1004SP2017-03-23
10896406002635Alcor SENTINELplusEN-1203SPEN-1203SP2017-03-23
10896406002666Alcor SENTINELplusEN-500SPEN-500SP2017-03-23
10896406002680Alcor SENTINELplusEN-1200SPEN-1200SP2017-03-23
10896406002703Alcor SENTINELplusE-1203SPE-1203SP2017-03-23
10896406002710Alcor SENTINELplusE-1004SPE-1004SP2017-03-23
00896406002355Sentinel®S-1000-SIS-1000-SI2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253009675KangarooCardinal Health 200, LLCLZH2026-05-12
10885380193071KangarooCardinal Health 200, LLCLZH2026-03-16
50885380193079KangarooCardinal Health 200, LLCLZH2026-03-16
10192253068900KangarooCardinal Health 200, LLCLZH2025-09-30
10192253068917KangarooCardinal Health 200, LLCLZH2025-09-30
00197886002300Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00197886008203Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00197886008210Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
20197886002304Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
20197886008207Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00704411019797SENTINEL® Enteral Feeding PumpAMSINO INTERNATIONAL, INC.LZH2025-06-25
03660812138345PUGGLEMEDWIN FRANCELZH2025-06-11
53660812136780PUGGLEMEDWIN FRANCELZH2025-06-11
10192253011135KangarooCardinal Health 200, LLCLZH2025-05-28
50192253011133KangarooCardinal Health 200, LLCLZH2025-05-28
10192253008456KangarooCardinal Health 200, LLCLZH2025-05-19
50192253008454KangarooCardinal Health 200, LLCLZH2025-05-19
10192253009682KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009859KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009965KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009680KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009857KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009963KangarooCardinal Health 200, LLCLZH2025-05-02
10192253008418KangarooCardinal Health 200, LLCLZH2025-04-29
10192253008432KangarooCardinal Health 200, LLCLZH2025-04-29
50192253008416KangarooCardinal Health 200, LLCLZH2025-04-29
50192253008430KangarooCardinal Health 200, LLCLZH2025-04-29
10885380184567KangarooCardinal Health 200, LLCLZH2025-03-23
10192253008159KangarooCardinal Health 200, LLCLZH2024-12-16
10192253023107KangarooCardinal Health 200, LLCLZH2024-12-16