FDA.reportPublic FDA data

NeoDevices, Inc.

Primary DI
10816340023015
Brand
NeoDevices, Inc.
Company
NEODEVICES INC
Model
ND-S5EL
Device description
5cc Oral dose syringe
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816340027846PackageGS1100In Commercial Distribution
10816340023015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081634002784610816340027846
1081634002301510816340023015

GMDN Terms#

Term, Definition table
TermDefinition
ENFit oral/enteral syringe, single-useA manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
866-636-6285info@neodevices.com

Regulatory Flags#

DUNS number
189670230
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816340021663ND60EL-HFND60EL-HF2026-10-13
00816340021632EL-SPIKE-MEL-SPIKE-M2026-06-01
00816340021649EL-SPIKE-FEL-SPIKE-F2026-06-01
00816340021656EL-S55-HFEL-S55-HF2026-06-01
00816340023162Transfer StrawND-S552026-02-05
10816340023145Marian MedicalETT-A-15502025-03-28
10816340021523NeoDevices, Inc.ND60-EL2016-09-24
10816340028355NeoDevices, Inc.ND60-EL2016-09-24
00816340023131SS-1660.13SS-1660.132024-04-17
10816340021097NeoDevices, Inc.LN22102016-09-24
10816340021103NeoDevices, Inc.LN22152016-09-24
10816340027921NeoDevices, Inc.LN22102016-09-24
10816340027938NeoDevices, Inc.LN22152016-09-24
10816340022117NeoDevices, Inc.ND-BF202016-09-24
10816340027808NeoDevices, Inc.ND-BF202016-09-24
00816340023124CT KITCT KIT2023-02-09
10816340023121CT KITCT KIT2023-02-09
10816340023008NeoDevices, Inc.ND-S3EL2016-09-24
10816340023022NeoDevices, Inc.ND-S10EL2016-09-24
10816340023039NeoDevices, Inc.ND-S20EL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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