AIA-PACK PAP CALIBRATOR SET

GUDID 04560189211582

TOSOH CORPORATION

Prostatic acid phosphatase (PAP) IVD, calibrator

• Primary Device ID: 04560189211582
• NIH Device Record Key: 5971ca46-57db-4f89-a48d-3cc4d8bbe6be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIA-PACK PAP CALIBRATOR SET
• Version Model Number: N/A
• Company DUNS: 690571724
• Company Name: TOSOH CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 614-317-1909
• Email: Levent.durukan@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com
• Phone: 650-615-8134
• Email: Dave.Wurtz@tosoh.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560189211582 [Primary]

FDA Product Code

• JFH: Acid Phosphatase (Prostatic), Tartrate Inhibited

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: 2018-03-29
• Device Publish Date: 2016-09-24

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