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Custom Procedure Kit

FDA UDI

Class II (US FDA UDI)

by Medivators Inc.

Identity

Trade Name
Custom Procedure Kit FDA UDI
Generic Name
Endoscopy preparation kit FDA UDI
Device Name
Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-piece Kit, Absorbant Pad, Lubricant, Gauze, Duoswift Squeese Cleaning Brush with Valve Brush, suction tubing, gowns and Nasal Cannula. FDA UDI
Model / Reference
4010500 FDA UDI
Description
Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-piece Kit, Absorbant Pad, Lubricant, Gauze, Duoswift Squeese Cleaning Brush with Valve Brush, suction tubing, gowns and Nasal Cannula. FDA UDI

Identifiers

Catalog Number
4010500 FDA UDI
Primary DI / UDI-DI
00677964150555 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

Custom Procedure 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 f877b4d5-fc63-49c2-84e6-6bb54d4de3cb 35 fields · synced May 30, 2026