SCS-1000 Calibrator

GUDID 14987562460370

SCS-1000 Universal Calibrator 1X2ML

SYSMEX CORPORATION

Full blood count IVD, calibrator

• Primary Device ID: 14987562460370
• NIH Device Record Key: 19107cc3-45b1-4f47-b54f-8d5a53f98303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCS-1000 Calibrator
• Version Model Number: 217685
• 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: 2 Milliliter
• Total Volume: 2 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	14987562460370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943268

FDA Product Code

• KSA: CALIBRATOR FOR RED-CELL AND WHITE-CELL COUNTING

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: 2016-08-04

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