Sperm Maintenance Medium 99176

GUDID 00857515006061

Sperm Maintenance Medium

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium

• Primary Device ID: 00857515006061
• NIH Device Record Key: 8a342a93-1f46-4b5d-9b42-1d2a90a24c98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sperm Maintenance Medium
• Version Model Number: 99176-12X5ML
• Catalog Number: 99176
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Device Count: 12
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com
• Phone: 8004375706
• Email: tmrequest@irvinesci.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Below -10°C
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006061 [Primary]
GS1	10857515006068 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991337

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-09-10

On-Brand Devices [Sperm Maintenance Medium]

• 00857515006061: Sperm Maintenance Medium
• 00893727002965: Sperm Maintenance Medium