Endo Carry-On Procedure Kit

FDA UDI

Class II (US FDA UDI)

by Medivators Inc.

Identity

Trade Name: Endo Carry-On Procedure Kit FDA UDI
Generic Name: Endoscopy preparation kit FDA UDI
Device Name: The ENDO CARRY-ON Procedure Kit contains all of the supplies and infection prevention products needed for endoscopic procedures FDA UDI
Model / Reference: CPK-104822-0001 FDA UDI
Description: The ENDO CARRY-ON Procedure Kit contains all of the supplies and infection prevention products needed for endoscopic procedures FDA UDI

Identifiers

Catalog Number: CPK1048220001 FDA UDI
Primary DI / UDI-DI: 00677964083259 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

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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscopy preparation kit

The Endo Carry-On Procedure Kit is a comprehensive endoscopy preparation kit designed for the preparation of patients undergoing gastrointestinal and urological procedures. This single-use, PM-exempt device includes all necessary supplies to support the procedure, excluding pharmaceuticals and containing no medical devices. The kit is intended for use in commercial distribution only.

Similar devices

Also classified as Endoscopy preparation kit.

Compliance EndoKit™ — Boston Scientific · Class I
Compliance EndoKit™ — Boston Scientific · Class I
VIA — US Endoscopy · Class II
VIA — US Endoscopy · Class II
Compliance EndoKit™ — Boston Scientific · Class I
Compliance EndoKit™ — Boston Scientific · Class I
Compliance EndoKit™ — Boston Scientific · Class I
VIA — US Endoscopy · Class II

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: Medivators Inc.

Sources (1)

FDA UDI 82e493ed-5aeb-427c-bc09-3759fb1c14c6 35 fields · synced Jun 20, 2026