Meter Trax 970X

GUDID 00847661003182

Meter Trax Control Trilevel MiniPak (A human whole blood control for glucose, hemoglobin and hematocrit.)

BIO-RAD LABORATORIES, INC.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 00847661003182
• NIH Device Record Key: 10e403a2-d15c-4aec-9a2a-09fec4451e18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meter Trax
• Version Model Number: 970X
• Catalog Number: 970X
• Company DUNS: 051624070
• Company Name: BIO-RAD LABORATORIES, 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	00847661003182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042336

FDA Product Code

• JPK: Mixture, hematology quality control

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: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [Meter Trax]

• 00847661003212: Meter Trax Control Level High (A human whole blood control for glucose, hemoglobin and hematocri
• 00847661003205: Meter Trax Control Level Mid (A human whole blood control for glucose, hemoglobin and hematocrit
• 00847661003199: Meter Trax Control Level Low (A human whole blood control for glucose, hemoglobin and hematocrit
• 00847661003182: Meter Trax Control Trilevel MiniPak (A human whole blood control for glucose, hemoglobin and hem
• 00847661003120: Meter Trax Control Trilevel (A human whole blood control for glucose, hemoglobin and hematocrit.