FDA.reportPublic FDA data

SENTINEL® Enteral Feeding Pump

Primary DI
00704411019797
Brand
SENTINEL® Enteral Feeding Pump
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
S-1000-SI
Published
2025-06-25
Public version status
New
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
00704411019797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00704411019797007044110197977044110197970704411019797

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825673239
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10704411017097AMSure ® Hydrophilic Latex Foley Catheters1AS41014HC2026-05-15
10704411017103AMSure ® Hydrophilic Latex Foley Catheters1AS41016HC2026-05-15
10704411017110AMSure ® Hydrophilic Latex Foley Catheters1AS41018HC2026-05-15
10704411017127AMSure ® Hydrophilic Latex Foley Catheters1AS41020HC2026-05-15
10704411017134AMSure ® Hydrophilic Latex Foley Catheters1AS41022HC2026-05-15
10704411017141AMSure ® Hydrophilic Latex Foley Catheters1AS41024HC2026-05-15
10704411017158AMSure ® Hydrophilic Latex Foley Catheters1AS42016HC2026-05-15
10704411017165AMSure ® Hydrophilic Latex Foley Catheters1AS42018HC2026-05-15
10704411017172AMSure ® Hydrophilic Latex Foley Catheters1AS42020HC2026-05-15
10704411017189AMSure ® Hydrophilic Latex Foley Catheters1AS42022HC2026-05-15
10704411017196AMSure ® Hydrophilic Latex Foley Catheters1AS42024HC2026-05-15
10704411021544AMSure® Cystoscopy/Bladder Irrigation Set1ABL4002026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation Set1ABL4042026-04-10
10704411018834AMSure ® SUTURE REMOVAL KIT1SRT0012026-04-03
10704411018841AMSure ® Suture Removal Kit1SRT0022026-04-03
10704411018858AMSure ® Suture Removal Kit1SRT001Z2026-04-03
40704411007464AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS35302026-04-03
40704411007471AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10102026-04-03
40704411007488AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10032026-04-03

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