FDA.reportPublic FDA data

Medline

Primary DI
20888277699820
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ENT921
Catalog number
ENT921
Device description
QCW, 14-16 FR, 21.5 CM, BROWN
Published
2021-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277699820PackageGS110In Commercial Distribution
10888277699823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827769982020888277699820
1088827769982310888277699823

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding/decompression tube clearing stemA non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency. It consists of a sheath and a stem clog disrupter (e.g., a wire or rod) designed to be magnetically coupled with a motorized actuator which facilitates the forward and backward movement of the disrupter inside the sheath. It typically has a collar to restrict the inserted length, and a diameter, appropriate for the installed feeding/decompression tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length21.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00AVOID EXCESSIVE HEAT
Special Storage Condition, Specify00KEEP DRY
Special Storage Condition, Specify00KEEP DRY. PROTECT FROM FREEZING. AVOID EXCESSIVE HEAT.
Special Storage Condition, Specify00KEEP DRY; AVOID EXCESSIVE HEAT; PROTECT FROM FREEZING
Special Storage Condition, Specify00PROTECT FROM FREEZING
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20197344159069MEDLINEMDT12091XXLMDT12091XXL2026-03-03
20197344159113MEDLINEMDTZ1210949ADMDTZ1210949AD2026-03-03
10653160393924MEDLINEBSIPIV1022ABSIPIV1022A2026-10-05
10653160394372MEDLINEARTNC245ARTNC2452026-10-05
10653160394631MEDLINECVI4880CCVI4880C2026-10-05
10653160395010MEDLINEBSIPIV1020ABSIPIV1020A2026-10-05
10653160395034MEDLINEARTNC246ARTNC2462026-10-05
10653160395195MEDLINEARTNC247ARTNC2472026-10-05
20080196182029GeminiGEM2115SGEM2115S2016-10-14
20080196182104GeminiGEM2118SGEM2118S2016-10-14
20080196182241GeminiGEM2120SGEM2120S2016-10-14
20080196182357GeminiGEM2124SGEM2124S2016-10-14
20080196183248GeminiGEM2130SGEM2130S2016-10-14
10653160349082MEDLINEDYNDV2513DYNDV25132021-11-18
10653160351849MEDLINEDYNDV2482BDYNDV2482B2022-04-04
10888277237681MEDLINEDYNDR1135DYNDR11352016-09-29
10653160393900MEDLINEBSIPIV1023BSIPIV10232026-10-01
10888277664395MEDLINEMPHUA120MPMPHUA120MP2026-10-01
20080196181893GeminiGEM1148SGEM1148S2016-10-14
20080196181954GeminiGEM2112SGEM2112S2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842071146368MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146399MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146405MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146450MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146467MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146511MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146528MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146559MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146566MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146597MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146603MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
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