← Back to catalogue

CT Enema Administration Kit: Enema Delivery System

FDA UDI

Class II (US FDA UDI)

by Bracco Diagnostics Inc.

Identity

Trade Name
CT Enema Administration Kit: Enema Delivery System FDA UDI
Generic Name
Enema tip, single-use FDA UDI
Device Name
CT Enema Kit (Empty) FDA UDI
Model / Reference
450002 FDA UDI
Description
CT Enema Kit (Empty) FDA UDI

Identifiers

Catalog Number
450002 FDA UDI
Primary DI / UDI-DI
10815112020207 FDA UDI
FDA Product Code
FGD FDA UDI
GMDN Term
Enema tip, single-use 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

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

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Enema tip, single-use

CT Enema Administration Kit: Enema Delivery System by Bracco Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enema tip, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bracco Diagnostics Inc.

Sources (1)

  • FDA UDI b210336a-c37b-4449-a81d-3c5c9014826a 35 fields · synced May 30, 2026