HemataSTAT II Centrifuge (Refurbished) R100-100

GUDID 00831829000397

HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate mircohematocrit determination using capillary or venous blood samples.

SEPARATION TECHNOLOGY, INC.

Microhaematocrit centrifuge Microhaematocrit centrifuge IVD Microhaematocrit centrifuge IVD Microhaematocrit centrifuge IVD Microhaematocrit centrifuge IVD Microhaematocrit centrifuge IVD Microhaematocrit centrifuge IVD Microhaematocrit centrifuge IVD

• Primary Device ID: 00831829000397
• NIH Device Record Key: 207b6e93-63fe-495d-a04c-d11e76e753d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemataSTAT II Centrifuge (Refurbished)
• Version Model Number: R100-100
• Catalog Number: R100-100
• Company DUNS: 195501127
• Company Name: SEPARATION TECHNOLOGY, INC.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00831829000397 [Primary]

FDA Product Code

• GKG: Centrifuge, Hematocrit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-05-18
• Device Publish Date: 2018-04-17

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• 00831829000304 - ClearCrit Mylar®Coated Glass Capillary Tubes: 2018-08-09
• 00831829000328 - ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes: 2018-08-09
• 00831829000403 - ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes: 2018-08-09