UltraCrit (Refurbished) R100-200

GUDID 00831829000380

UltraCrit Hematocrit measurement device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whole blood. For In-Vitro diagnostics use.

SEPARATION TECHNOLOGY, INC.

Haematocrit analyser IVD, automated

• Primary Device ID: 00831829000380
• NIH Device Record Key: 8428b077-9cda-437f-9826-89397e326d6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraCrit (Refurbished)
• Version Model Number: R100-200
• Catalog Number: R100-200
• Company DUNS: 195501127
• Company Name: SEPARATION TECHNOLOGY, INC.
• 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: 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
• 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
• 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
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00831829000380 [Primary]

FDA Product Code

• GKF: Instrument, Hematocrit, Automated

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: 2017-09-28

Devices Manufactured by SEPARATION TECHNOLOGY, INC.

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• 00831829000410 - HemataSTAT II Centrifuge: 2022-04-08 HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate mircohematocrit det
• 00831829000267 - ClearCRIT® Plastic Capillary Tubes: 2018-08-09
• 00831829000281 - ClearCRIT® Plastic Capillary Tubes: 2018-08-09
• 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