uTASWako i30 991-60301

GUDID 00856626006229

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

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• Primary Device ID: 00856626006229
• NIH Device Record Key: e1c5d335-3d8f-42aa-9f57-c130f38b72bb
• Commercial Distribution Discontinuation: 2020-10-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: uTASWako i30
• Version Model Number: 991-60301
• Catalog Number: 991-60301
• Company DUNS: 690598875
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856626006229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100464

FDA Product Code

• OUE: Micro Total Analysis Instrument System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-26
• Device Publish Date: 2020-06-01

On-Brand Devices [uTASWako i30]

• 00856626006229: In-Vitro Diagnostic Use
• 04987481164680: In-Vitro Diagnostic Use