FDA.reportPublic FDA data

Alcor SENTINELplus

Primary DI
00896406002669
Brand
Alcor SENTINELplus
Company
ALCOR SCIENTIFIC INC.
Model
EN-500SP
Catalog number
EN-500SP
Device description
Enteral Feeding Pump Bag, 500ml bag, back, NS Copy
Published
2017-05-05
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
00896406002669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896406002669008964060026698964060026690896406002669

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
Expiration 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
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
00896406002362Sentinel®S-2000-6S-2000-62016-10-03

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Primary DI, Brand, Company table
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10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
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10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
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08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
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10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
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10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
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10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13