ISolate® Stock Solution 99275

GUDID 00857515006269

ISolate® Stock Solution Custom packaging configuration. Only distributed in Japan.

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium

• Primary Device ID: 00857515006269
• NIH Device Record Key: 1345a1d8-95b5-4f06-b5da-3a61cffd3c5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISolate® Stock Solution
• Version Model Number: 99275-12x6ML
• Catalog Number: 99275
• 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: 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: 6 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006269 [Primary]
GS1	18575150062691 [Unit of Use]

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: 2017-12-31

On-Brand Devices [ISolate® Stock Solution]

• 00857515006269: ISolate® Stock Solution Custom packaging configuration. Only distributed in Japan.
• 00857515006016: ISolate® Stock Solution