FDA.reportPublic FDA data

Alcor SENTINELplus

Primary DI
10896406002628
Brand
Alcor SENTINELplus
Company
ALCOR SCIENTIFIC INC.
Model
EN-1004SP
Catalog number
EN-1004SP
Device description
Enteral Feeding Pump Spike Set, ENFit, adapter, NS
Published
2017-03-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902641000RPI ENTERAL FEEDING BAG 1000ML AND 500MLRidge Products, Inc.1990-10-01KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10896406002628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1089640600262810896406002628

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid of nutrients for administration to a patient through an enteral tube that provides direct access to the stomach, duodenum, or jejunum; it is not intended for intravenous (IV) administration. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an enteral feeding set] and is not intended to be directly connected to the invasive feeding tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
884153748
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
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
00896406002362Sentinel®S-2000-6S-2000-62016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770007557CORFLO* Safety PEG KitAvanos Medical, Inc.KNT2026-08-14
00842071146436MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071146443MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
10192253006834Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006841Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
00860007229428QoraCM TECHNOLOGIES, INC.KNT2025-03-12
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
08015262022259VYGONVygon CorporationKNT2024-05-08
10192253007565ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007589ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007602ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007626ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007640ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007763ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007800KangarooCardinal Health 200, LLCKNT2024-04-12