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Enteral

FDA UDI

Class I (US FDA UDI)

by Gbuk Enteral Limited

Identity

Trade Name
Enteral FDA UDI
Generic Name
Gastric drainage/decompression bag FDA UDI
Device Name
Enteral, Drainage Bag, EVA, Single Use 1000ml FDA UDI
Model / Reference
DBISO-1000 FDA UDI
Description
Enteral, Drainage Bag, EVA, Single Use 1000ml FDA UDI

Identifiers

Catalog Number
DBISO-1000 FDA UDI
Primary DI / UDI-DI
05060460843666 FDA UDI
FDA Product Code
FFD FDA UDI
GMDN Term
Gastric drainage/decompression bag FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4370 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

Yes

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 Safe FDA UDI

Category: Gastric drainage/decompression bag

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

Similar devices

Also classified as Gastric drainage/decompression bag.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gbuk Enteral Limited

Sources (1)

  • FDA UDI 2fc90fc4-1c21-4de1-8f49-b4fb84962b3e 34 fields · synced May 30, 2026