BD Kiestra™ Regular Base 446096

GUDID 00382904460969

BD Kiestra™ Regular Base

BD Kiestra B.V.

Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD Laboratory container/microscope slide robotic transfer system IVD

• Primary Device ID: 00382904460969
• NIH Device Record Key: 5e2321ec-6d93-4d5f-89db-4f8fef1094f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Kiestra™ Regular Base
• Version Model Number: 446096
• Catalog Number: 446096
• Company DUNS: 417876166
• Company Name: BD Kiestra B.V.
• 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: true
• Expiration Date: false
• 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(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904460969 [Primary]

FDA Product Code

• JQP: Calculator/data processing module, for clinical use

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: 2023-10-31
• Device Publish Date: 2023-10-23

Devices Manufactured by BD Kiestra B.V.

• 00382904460969 - BD Kiestra™ Regular Base: 2023-10-31BD Kiestra™ Regular Base
• 00382904460969 - BD Kiestra™ Regular Base: 2023-10-31 BD Kiestra™ Regular Base
• 00382904460976 - BD Kiestra™ Main Base: 2023-10-30 BD Kiestra™ Main Base
• 00382904469443 - BD Kiestra™ U-Turn: 2023-10-30 BD Kiestra U-turn
• 00382904469467 - BD Kiestra™ Straight: 2023-10-30 BD Kiestra Straight
• 00382904460921 - BD Kiestra™ T-junction: 2023-10-27 BD Kiestra™ T-junction
• 00382904460938 - BD Kiestra™ ErgonomicA Connector R: 2023-10-27 BD Kiestra™ ErgonomicA Connector R
• 00382904460945 - BD Kiestra™ ErgonomicA Connector L: 2023-10-27 BD Kiestra™ ErgonomicA Connector L
• 00382904460983 - BD Kiestra™ Corner: 2023-10-27 BD Kiestra™ Corner