ProteX

FDA UDI

Class II (US FDA UDI)

by Rsi Technology Group, Llc

Identity

Trade Name: ProteX FDA UDI
Generic Name: Semen specimen collection container FDA UDI
Device Name: A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device. FDA UDI
Model / Reference: 1 FDA UDI
Description: A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device. FDA UDI

Identifiers

Catalog Number: 10001 FDA UDI
Primary DI / UDI-DI: B686100010 FDA UDI
FDA Product Code: PUD FDA UDI
GMDN Term: Semen specimen collection container FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6160 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Semen specimen collection container

ProteX by Rsi Technology Group, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Semen specimen collection container.

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Male-FactorPakTM — APEX MEDICAL TECHNOLOGIES, INC. · Class II
Sperm Collection Container — Vitrolife Sweden AB · Class II
ProteX — RSI TECHNOLOGY GROUP, LLC · Class II
ProteX — RSI TECHNOLOGY GROUP, LLC · Class II
ProteX Safe-Seal — RSI TECHNOLOGY GROUP, LLC · Class II
NovoSort — RSI TECHNOLOGY GROUP, LLC · Class II

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: Rsi Technology Group, Llc

Sources (1)

FDA UDI 3dacf8a2-6864-4865-8815-17898390fbb7 35 fields · synced May 29, 2026