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Retention Cuff Inflator

FDA UDI

Class II (US FDA UDI)

by Bracco Diagnostics Inc.

Identity

Trade Name
Retention Cuff Inflator FDA UDI
Generic Name
Barium enema catheter FDA UDI
Device Name
One Shot Cuff Inflator FDA UDI
Model / Reference
900405 FDA UDI
Description
One Shot Cuff Inflator FDA UDI

Identifiers

Catalog Number
900405 FDA UDI
Primary DI / UDI-DI
10815112020887 FDA UDI
FDA Product Code
FGD FDA UDI
GMDN Term
Barium enema catheter 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Barium enema catheter

Retention Cuff Inflator by Bracco Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Barium enema catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bracco Diagnostics Inc.

Sources (1)

  • FDA UDI 53b0064c-8c28-4b8c-a225-73a3f94754c5 35 fields · synced Jun 8, 2026