BD MiniDraw Capillary Tube Adapter H&H

Basic Information

• Brand Name: BD MiniDraw Capillary Tube Adapter H&H
• Primary DI: 00850058457048
• Version / Model: 366619-10
• Catalog Number: 366619-10
• Company Name: Babson Diagnostics, Inc.
• Labeler DUNS: 059454260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-12-09
• Public Version: 1
• Public Version Date: 2025-12-17
• Public Version Status: New
• Public Device Record Key: 093b69fb-8d68-4aef-8705-d420a84d04c2

Device Description

BD MiniDraw Capillary Tube Adapter H&H Sysmex XN Only

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62010	Instrument/analyser test tube rack adaptor IVD	A device intended to be used on-board an in vitro diagnostic laboratory instrument or analyser to allow test tubes or vials of a nonstandard size to be placed onto an instrument/analyser test tube rack. It is typically made of metal or plastic. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00382903666195	GS1
Primary	00850058457048	GS1

Premarket Submissions

Submission Number	Supplement Number
K230493	000