FDA.reportPublic FDA data

NeoDevices, Inc.

Primary DI
10816340023039
Brand
NeoDevices, Inc.
Company
NEODEVICES INC
Model
ND-S20EL
Device description
20cc 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
10816340027860PackageGS1100In Commercial Distribution
10816340023039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081634002786010816340027860
1081634002303910816340023039

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
10816340023015NeoDevices, Inc.ND-S5EL2016-09-24
10816340023022NeoDevices, Inc.ND-S10EL2016-09-24

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Primary DI, Brand, Company table
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00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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