BD Vacutainer UltraTouch Push Button Blood Collection Set

Tubes, Vials, Systems, Serum Separators, Blood Collection

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Vacutainer Ultratouch Push Button Blood Collection Set.

Pre-market Notification Details

Device IDK212724
510k NumberK212724
Device Name:BD Vacutainer UltraTouch Push Button Blood Collection Set
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
ContactKatherine Kenner Lemus
CorrespondentKatherine Kenner Lemus
Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-27
Decision Date2022-02-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903673921 K212724 000
00382903673919 K212724 000
00382903673650 K212724 000
00382903673643 K212724 000
00382903673636 K212724 000
30382903673934 K212724 000
30382903673927 K212724 000
30382903673910 K212724 000
30382903673651 K212724 000
30382903673644 K212724 000
00382903673926 K212724 000
30382903686866 K212724 000
30382903686842 K212724 000
50382903673914 K212724 000
50382903673655 K212724 000
50382903673648 K212724 000
50382903673631 K212724 000
00382903673933 K212724 000
30382903686897 K212724 000
30382903686880 K212724 000
30382903686873 K212724 000
30382903686859 K212724 000
30382903673637 K212724 000

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