← Back to catalogue

EZ-Advancer

FDA UDI

Class II (US FDA UDI)

by H R Pharmaceuticals, Inc.

Identity

Trade Name
EZ-Advancer FDA UDI
Generic Name
Single-administration urethral catheterization kit, single-use FDA UDI
Device Name
EZ-Advancer® Closed System Intermittent Catheter Kit FDA UDI
Model / Reference
AKS14 FDA UDI
Description
EZ-Advancer® Closed System Intermittent Catheter Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00850058254777 FDA UDI
FDA Product Code
KOD FDA UDI
GMDN Term
Single-administration urethral catheterization kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Single-administration urethral catheterization kit, single-use

EZ-Advancer by H R Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-administration urethral catheterization kit, 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
H R Pharmaceuticals, Inc.

Sources (1)

  • FDA UDI 5a7bf88e-1890-4410-8959-8f1436da7f1d 34 fields · synced May 30, 2026