X-CAL Calibrator

GUDID 14987562460592

X-Cal FSR Kit (5X4.6ML)

SYSMEX CORPORATION

Full blood count IVD, calibrator

• Primary Device ID: 14987562460592
• NIH Device Record Key: 3c6246ac-4b6b-41bc-a503-013536c79f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-CAL Calibrator
• Version Model Number: 110-4008-0
• Company DUNS: 690664461
• Company Name: SYSMEX 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: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com

Device Dimensions

• Total Volume: 4.6 Milliliter
• Total Volume: 4.6 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	14987562460592 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083200

FDA Product Code

• KRX: CALIBRATOR FOR CELL INDICES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-18
• Device Publish Date: 2017-10-06

On-Brand Devices [X-CAL Calibrator]

• 14987562460592: X-Cal FSR Kit (5X4.6ML)
• 14987562460585: X-Cal Hematology Calibrator (4.6ML)