ProteX

Basic Information

• Brand Name: ProteX
• Primary DI: B6861PC0010SRS010000
• Version / Model: 1
• Catalog Number: 1PC0010SRS010000
• Company Name: Reproductive Solutions
• Labeler DUNS: 118022050
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-02-01
• Public Version: 1
• Public Version Date: 2024-02-09
• Public Version Status: New
• Public Device Record Key: 26ba117d-76ad-4b1b-8026-e672394d0be0

Device 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. Case of 10 units.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	884.6160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63772	Semen specimen collection container	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B6861PC0010SRS010000	HIBCC
Unit of Use	B68610001	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]