AccessGUDID - DEVICE: Babson Sample Preparation Device (00850058457017)

GUDID

Device Identifier (DI) Information

Brand Name: Babson Sample Preparation Device
Version or Model: Babson Sample Preparation Device
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SE-9-02001
Company Name: Babson Diagnostics, Inc.

Primary DI Number: 00850058457017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 059454260 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36465	General-purpose centrifuge IVD	An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0239cf3-657e-432a-865b-3843e6d0ba87
Public Version Date: May 21, 2024
Public Version Number: 1
DI Record Publish Date: May 13, 2024