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NeoDevices, Inc.

FDA UDI

Class II (US FDA UDI)

by Neodevices Inc

Identity

Trade Name
NeoDevices, Inc. FDA UDI
Generic Name
Gastrostomy tube Y-piece connector FDA UDI
Device Name
36" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enteral only connector with 2" orange stripe tube with enteral only connector FDA UDI
Model / Reference
ND36EOY FDA UDI
Description
36" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enteral only connector with 2" orange stripe tube with enteral only connector FDA UDI

Identifiers

Primary DI / UDI-DI
10816340022063 FDA UDI
FDA Product Code
KNT FDA UDI
GMDN Term
Gastrostomy tube Y-piece connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Gastrostomy tube Y-piece connector

NeoDevices, Inc. by Neodevices Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrostomy tube Y-piece connector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neodevices Inc

Sources (1)

  • FDA UDI 00a92387-f2bb-49e0-a307-1c2404e60a6a 34 fields · synced May 30, 2026