Complete Early Cleavage Medium with DSS 90142

GUDID 00893727002286

Complete Early Cleavage (ECM) With DSS

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

• Primary Device ID: 00893727002286
• NIH Device Record Key: 91cec091-a17c-4c05-8c01-3f93b9f82908
• Commercial Distribution Discontinuation: 2021-06-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Complete Early Cleavage Medium with DSS
• Version Model Number: 90142-2X20mL
• Catalog Number: 90142
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Device Count: 2
• 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

Device Dimensions

• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893727002286 [Primary]
GS1	10893727002283 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033462

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: 5
• Public Version Date: 2021-10-20
• Device Publish Date: 2016-09-10

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• 00893727002286 - Complete Early Cleavage Medium with DSS: 2021-10-20Complete Early Cleavage (ECM) With DSS
• 00893727002286 - Complete Early Cleavage Medium with DSS: 2021-10-20 Complete Early Cleavage (ECM) With DSS