e-CHECK(XS)

GUDID 14987562460578

E-Check (XS) 5X1.5MLX2 Normal/High

SYSMEX CORPORATION

Full blood count IVD, control

• Primary Device ID: 14987562460578
• NIH Device Record Key: 08b57ce5-b2fc-4ed6-b252-9d1fe3258b32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-CHECK(XS)
• Version Model Number: 199-5002-0
• 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: 1.5 Milliliter
• Total Volume: 1.5 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	14987562460578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994388

FDA Product Code

• GLQ: MIXTURE, CONTROL, WHITE-CELL AND RED-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: 2016-08-05

On-Brand Devices [e-CHECK(XS)]

• 14987562460578: E-Check (XS) 5X1.5MLX2 Normal/High
• 14987562460561: E-Check (XS) 5X1.5MLX1 Low