Male-FactorPakTM

FDA UDI

Class II (US FDA UDI)

by Apex Medical Technologies, Inc.

Identity

Trade Name: Male-FactorPakTM FDA UDI
Generic Name: Semen specimen collection container FDA UDI
Device Name: Specimen Collection Container used to collect semen. FDA UDI
Model / Reference: MFP-130 FDA UDI
Description: Specimen Collection Container used to collect semen. FDA UDI

Identifiers

Catalog Number: MFP-130 FDA UDI
Primary DI / UDI-DI: 00862242000336 FDA UDI
510(k) Number: K954791 FDA UDI
FDA Product Code: HIS FDA UDI
GMDN Term: Semen specimen collection container FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Semen specimen collection container

Male-FactorPakTM by Apex Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ProteX — RSI TECHNOLOGY GROUP, LLC · Class II
NovoSort — RSI TECHNOLOGY GROUP, LLC · Class II
Sperm Collection Container — Vitrolife Sweden AB · Class II
NovoSort — RSI TECHNOLOGY GROUP, LLC · Class II

Cleared under the same submission

K954791 also covers:

Hy-GeneTM Seminal Fluid Collection Kit — APEX MEDICAL TECHNOLOGIES, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Apex Medical Technologies, Inc.

Sources (1)

FDA UDI f1601c15-27a8-4bd5-a780-d4fa4c1dbf73 37 fields · synced May 30, 2026