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Miller Enema Air Tip with Non-Latex Retention Cuff

FDA UDI

Class II (US FDA UDI)

by Bracco Diagnostics Inc.

Identity

Trade Name
Miller Enema Air Tip with Non-Latex Retention Cuff FDA UDI
Generic Name
Enema tip, single-use FDA UDI
Device Name
Non latex Retention Enema Tip FDA UDI
Model / Reference
901201 FDA UDI
Description
Non latex Retention Enema Tip FDA UDI

Identifiers

Catalog Number
901201 FDA UDI
Primary DI / UDI-DI
10815112021181 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 48 French FDA UDI

Category: Enema tip, single-use

Miller Enema Air Tip with Non-Latex Retention Cuff 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

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Manufacturer

Manufacturer
Bracco Diagnostics Inc.

Sources (1)

  • FDA UDI 7498e7dd-c402-4e7f-8770-4948804e724a 36 fields · synced May 30, 2026