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Enteral

FDA UDI

Class II (US FDA UDI)

by Gbuk Enteral Limited

Identity

Trade Name
Enteral FDA UDI
Generic Name
Enteral tube extension, single-use FDA UDI
Device Name
Enteral Accessories Single Use Enteral Extension Set 75 cm FDA UDI
Model / Reference
ESCF.075-ISOSAF-US FDA UDI
Description
Enteral Accessories Single Use Enteral Extension Set 75 cm FDA UDI

Identifiers

Catalog Number
ESCF.075-ISOSAF-US FDA UDI
Primary DI / UDI-DI
05060999351564 FDA UDI
FDA Product Code
PIF FDA UDI
GMDN Term
Enteral tube extension, single-use 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Enteral tube extension, single-use

Enteral by Gbuk Enteral Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enteral tube extension, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI eace346b-dfd9-43d8-8df7-d09b0664fd46 34 fields · synced Jun 1, 2026