Hy-GeneTM Seminal Fluid Collection Kit ACK-121

GUDID 00862242000312

Specimen Collection Container for the collection of semen.

APEX MEDICAL TECHNOLOGIES, INC.

Semen specimen collection container

• Primary Device ID: 00862242000312
• NIH Device Record Key: e7c79606-6e84-4aa7-ba71-abb95e86f85b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hy-GeneTM Seminal Fluid Collection Kit
• Version Model Number: ACK-121
• Catalog Number: ACK-121
• Company DUNS: 154115885
• Company Name: APEX MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com
• Phone: 858-535-0012
• Email: sales@apexfertility.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862242000305 [Primary]
GS1	00862242000312 [Package]; Contains: 00862242000305; Package: Box [30 Units]; In Commercial Distribution
GS1	00862242000329 [Package]; Contains: 00862242000305; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954791

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-14
• Device Publish Date: 2024-09-05

Devices Manufactured by APEX MEDICAL TECHNOLOGIES, INC.

• 00862242000312 - Hy-GeneTM Seminal Fluid Collection Kit: 2026-01-14Specimen Collection Container for the collection of semen.
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