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Essential Kit

FDA UDI

Class II (US FDA UDI)

by Medivators Inc.

Identity

Trade Name
Essential Kit FDA UDI
Generic Name
Endoscopy preparation kit FDA UDI
Device Name
Essential Kit includes Olympus DEFENDO Valves, Basin, Bedside Sponge, Transport Pad, Lube, Gauze, Cleaning Brush, Dirty Scope Label, and Suction Tubing FDA UDI
Model / Reference
4000941 FDA UDI
Description
Essential Kit includes Olympus DEFENDO Valves, Basin, Bedside Sponge, Transport Pad, Lube, Gauze, Cleaning Brush, Dirty Scope Label, and Suction Tubing FDA UDI

Identifiers

Catalog Number
4000941 FDA UDI
Primary DI / UDI-DI
40677964008625 FDA UDI
FDA Product Code
NWU FDA UDI
GMDN Term
Endoscopy preparation kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopy preparation kit

Essential Kit by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopy preparation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medivators Inc.

Sources (1)

  • FDA UDI c74d2f20-9ae5-41e6-b5e9-5bba5c08f62b 35 fields · synced May 30, 2026