VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE

Tubes, Vials, Systems, Serum Separators, Blood Collection

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Vacutainer Brand Plus Sodium Heparin Tube.

Pre-market Notification Details

• Device ID: K944566
• 510k Number: K944566
• Device Name: VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Contact: Melanie T O'neill
• Correspondent: Melanie T O'neill; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-09-21
• Decision Date: 1994-11-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50382903680363	K944566	000
50382903680356	K944566	000
30382903676713	K944566	000
30382903678748	K944566	000
30382903678724	K944566	000
30382903678717	K944566	000
30382903680376	K944566	000
30382903678786	K944566	000