← Back to catalogue

MiniACE Low Profile Antegrade Continence Enema Irrigation Set

FDA UDI

Class II (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name
MiniACE Low Profile Antegrade Continence Enema Irrigation Set FDA UDI
Generic Name
Caecostomy tube FDA UDI
Device Name
24" Right Angle Irrigation Set - For Use with the MiniACE® Button (Pouched), MDR FDA UDI
Model / Reference
E2-2421 FDA UDI
Description
24" Right Angle Irrigation Set - For Use with the MiniACE® Button (Pouched), MDR FDA UDI

Identifiers

Catalog Number
E2-2421, 2-2421 FDA UDI
Primary DI / UDI-DI
00842071132187 FDA UDI
510(k) Number
K180026 FDA UDI
FDA Product Code
KNT FDA UDI
EXD FDA UDI
PIF FDA UDI
GMDN Term
Caecostomy tube FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
876.5895 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

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
Length — 24 Inch FDA UDI

Category: Caecostomy tube

MiniACE Low Profile Antegrade Continence Enema Irrigation Set by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Caecostomy tube.

Cleared under the same submission

K180026 also covers:

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
Applied Medical Technology, Inc.

Sources (1)

  • FDA UDI d901aa3d-8e3e-472a-b7e2-ccca68e2b124 37 fields · synced Jun 9, 2026