FDA.reportPublic FDA data

Alcor SENTINELplus

Primary DI
00896406002638
Brand
Alcor SENTINELplus
Company
ALCOR SCIENTIFIC INC.
Model
EN-1203SP
Catalog number
EN-1203SP
Device description
Enteral Feeding Gravity Set, ENFit, secure lock tip, adapter, NS
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
K902729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902729000R.P.I. GRAVITY SAFE FEEDING BAGRidge Products, Inc.1990-08-08KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896406002638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896406002638008964060026388964060026380896406002638

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997889MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997926MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997933MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997940MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997957MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00816340021663ND60EL-HFNEODEVICES INCKNT2026-10-13
00842071145774MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071145781MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146573MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146580MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146610MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146627MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146658MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146665MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00350770005881CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00350770007915CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00842071146290MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146306MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146313MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146320MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146351MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29