ISolate® Concentrate 99306

GUDID 00857515006023

ISolate Custom package configuration

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium

• Primary Device ID: 00857515006023
• NIH Device Record Key: 5499e179-71f0-47f5-85d2-e3149b2e9004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISolate® Concentrate
• Version Model Number: 99306-1L
• Catalog Number: 99306
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, 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: 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

Device Dimensions

• Total Volume: 1 Liter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991341

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

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