Babson Sample Preparation Device SE-9-02001

GUDID 00850058457017

The Babson Sample Preparation Device is a class I exempt device that falls within 21 CFR 862.2050, General purpose laboratory equipment labeled or promoted for a specific medical use, in accordance with FDA regulations. It serves as a sample preparation device used to automate the mixing, centrifugation, and refrigeration of capillary blood samples for chemistry and hematology testing. The Babson Sample Preparation Device is not an analyzer and does not produce test results. The Babson Sample Preparation Device is intended for use only with the Becton, Dickinson, and Company’s BD MiniDraw ™ H&H ™ Capillary Blood Collection Tube and BD MiniDraw ™ SST ™ Capillary Blood Collection Tube, which are used to collect capillary blood from the customer’s fingertip; the H&H will be mixed, and the SST will be mixed and centrifuged by the Babson Sample Preparation Device. The device is intended to be able to process up to 60 tubes per day across multiple customers.

Babson Diagnostics, Inc.

General-purpose centrifuge IVD

• Primary Device ID: 00850058457017
• NIH Device Record Key: d0239cf3-657e-432a-865b-3843e6d0ba87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babson Sample Preparation Device
• Version Model Number: Babson Sample Preparation Device
• Catalog Number: SE-9-02001
• Company DUNS: 059454260
• Company Name: Babson Diagnostics, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850058457017 [Primary]

FDA Product Code

• JQC: Centrifuges (Micro, Ultra, Refrigerated) 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: 2024-05-21
• Device Publish Date: 2024-05-13

Devices Manufactured by Babson Diagnostics, Inc.

• 00850058457031 - BD MiniDraw Capillary Tube Adapter SST: 2025-12-17 BD MiniDraw Capillary Tube Adapter SST
• 00382903666171 - BD MiniDraw Finger Sizing Tool: 2025-12-17 BD MiniDraw Finger Sizing Tool
• 00850058457017 - Babson Sample Preparation Device: 2024-05-21The Babson Sample Preparation Device is a class I exempt device that falls within 21 CFR 862.2050, General purpose laboratory equipment labeled or promoted for a specific medical use, in accordance with FDA regulations. It serves as a sample preparation device used to automate the mixing, centrifugation, and refrigeration of capillary blood samples for chemistry and hematology testing. The Babson Sample Preparation Device is not an analyzer and does not produce test results. The Babson Sample Preparation Device is intended for use only with the Becton, Dickinson, and Company’s BD MiniDraw ™ H&H ™ Capillary Blood Collection Tube and BD MiniDraw ™ SST ™ Capillary Blood Collection Tube, which are used to collect capillary blood from the customer’s fingertip; the H&H will be mixed, and the SST will be mixed and centrifuged by the Babson Sample Preparation Device. The device is intended to be able to process up to 60 tubes per day across multiple customers.
• 00850058457017 - Babson Sample Preparation Device: 2024-05-21 The Babson Sample Preparation Device is a class I exempt device that falls within 21 CFR 862.2050, General purpose laboratory eq
• 00850058457000 - Babson Hand Warmer: 2024-01-22 The Babson Hand Warmer is a powered heating device that provides heat to the palm of the hand to aid in blood collection. It is