Ethox Medical

FDA UDI

Class II (US FDA UDI)

by Ethox Medical, Llc

Identity

Trade Name: Ethox Medical FDA UDI
Generic Name: Gastric lavage kit FDA UDI
Device Name: Gastric Lavage Kit with 32fr Tubes and (2) 25g Activated Charcoal with Aqua FDA UDI
Model / Reference: 950095603 FDA UDI
Description: Gastric Lavage Kit with 32fr Tubes and (2) 25g Activated Charcoal with Aqua FDA UDI

Identifiers

Primary DI / UDI-DI: 10889483150047 FDA UDI
510(k) Number: K962850 FDA UDI
FDA Product Code: KDH FDA UDI
GMDN Term: Gastric lavage kit 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 32 French FDA UDI

Category: Gastric lavage kit

Ethox Medical by Ethox Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastric lavage kit.

Bard® Levin Duodenal Tube — C. R. Bard, Inc. · Class II
Bard® Stomach/Intestinal Tube — C. R. Bard, Inc. · Class II
Bard® Stomach/Evacuator Tube — C. R. Bard, Inc. · Class II
Bard® Baker Jejunostomy Catheter — C. R. Bard, Inc. · Class II
Bard® Levin Duodenal Tube — C. R. Bard, Inc. · Class II
Bard® Levin Duodenal Tubes — C. R. Bard, Inc. · Class II
Bard® Stomach/Intestinal Tube — C. R. Bard, Inc. · Class II
Bard® Levin Tube — C. R. Bard, Inc. · Class II

Cleared under the same submission

K962850 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ethox Medical, Llc

Sources (1)

FDA UDI e7e9d73c-4ddf-4c15-bb48-e65ba2799fdc 37 fields · synced May 30, 2026