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BD Vacutainer UltraTouch Push Button Blood Collection Set

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K212724Ref 367363Ref 367391Ref 367393Ref 367364Ref 368687Ref 368689Ref 368688

by Becton, Dickinson and Company

Identity

Trade Name
Vacutainer ULTRATOUCH EUDAMED
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set FDA UDI
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with PAH FDA UDI
Generic Name
Blood collection set, invasive FDA UDI
Device Name
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set EUDAMEDFDA UDI
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with Pre-Attached Holder EUDAMED
WINGSET PBBCS UTW PP 25X.75 7 LUER FDA UDI
WINGSET PBBCS UTW PP 25X.75 12 LUER FDA UDI
UT-PBBCS 23G 12 PAH CE FDA UDI
WINGSET PBBCS UTW PP 23X.75 12 LUER FDA UDI
UT-PBBCS 25G 12 PAH CE FDA UDI
UT-PBBCS 21G 12 PAH CE FDA UDI
Model / Reference
367391 EUDAMEDFDA UDI
367363 EUDAMEDFDA UDI
368688 EUDAMEDFDA UDI
367393 EUDAMEDFDA UDI
367364 EUDAMEDFDA UDI
368687 EUDAMEDFDA UDI
368689 EUDAMEDFDA UDI
Description
WINGSET PBBCS UTW PP 25X.75 7 LUER FDA UDI
WINGSET PBBCS UTW PP 25X.75 12 LUER FDA UDI
UT-PBBCS 23G 12 PAH CE FDA UDI
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set FDA UDI
WINGSET PBBCS UTW PP 23X.75 12 LUER FDA UDI
UT-PBBCS 25G 12 PAH CE FDA UDI
UT-PBBCS 21G 12 PAH CE FDA UDI

Identifiers

Catalog Number
367391 FDA UDI
367363 FDA UDI
368688 FDA UDI
367393 FDA UDI
367364 FDA UDI
368687 FDA UDI
368689 FDA UDI
Primary DI / UDI-DI
30382903673910 EUDAMEDFDA UDI
30382903673637 EUDAMEDFDA UDI
30382903686880 EUDAMEDFDA UDI
30382903673934 EUDAMEDFDA UDI
30382903673644 EUDAMEDFDA UDI
30382903686873 EUDAMEDFDA UDI
30382903686897 EUDAMEDFDA UDI
Basic UDI-DI
038290BDHNKPEPZP EUDAMED
038290KELSPJXNCT EUDAMED
Unit of Use DI
00382903673636 EUDAMED
00382903673919 EUDAMED
00382903673933 EUDAMED
00382903673643 EUDAMED
00382903686872 EUDAMED
00382903686896 EUDAMED
00382903686889 EUDAMED
510(k) Number
K212724 FDA 510(k)FDA UDI
FDA Product Code
JKA FDA 510(k)FDA UDI
FPA FDA UDI
EMDN Code
A01010201 BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS EUDAMED
GMDN Term
Blood collection set, invasive FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 862.1675 FDA 510(k)
Regulation Number
862.1675 FDA 510(k)FDA UDI
880.5440 FDA UDI
Market of Registration
Belgium EUDAMED
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

BD Vacutainer UltraTouch Push Button Blood Collection Set by Becton, Dickinson and Company — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (15)

  • FDA 510(k) K212724 24 fields · synced Jul 25, 2026
  • FDA UDI 578a023c-12e5-40d5-b8b3-d6a28560cac1 36 fields · synced May 29, 2026
  • FDA UDI 08cafcf1-6864-4dfe-ac3d-8d239a91ff92 36 fields · synced May 29, 2026
  • FDA UDI 918cc991-855a-40b6-8df7-825e522569f3 36 fields · synced May 29, 2026
  • FDA UDI 3df84fa5-cfaa-416d-80e6-9d0ebd832ae2 35 fields · synced May 29, 2026
  • FDA UDI eae8b08f-edcb-4d25-ae4b-d63e675a1499 36 fields · synced May 30, 2026
  • FDA UDI 5abb992f-f382-48e8-9de5-69d4b1a543b6 36 fields · synced May 30, 2026
  • FDA UDI 9e13fd61-8a11-4c02-beeb-65aaff6997f4 36 fields · synced May 30, 2026
  • EUDAMED d1a84894-2135-413a-be22-db3933935b76 61 fields · synced Jun 20, 2026
  • EUDAMED 61eb449d-43d6-4b6b-aaa4-f60e305c0266 61 fields · synced Jul 9, 2026
  • EUDAMED b7866528-18f9-440b-9813-ddba9b54012c 61 fields · synced Jul 9, 2026
  • EUDAMED 8bd379bd-376d-41b9-acae-9afe46c76edb 61 fields · synced Jul 13, 2026
  • EUDAMED 9e27629c-7528-4c5d-a39c-42bc2a81bf5d 61 fields · synced Jul 18, 2026
  • EUDAMED 51ae00a8-21c5-4e96-9103-d7c585794afa 61 fields · synced Jul 19, 2026
  • EUDAMED 5466d43a-463d-461a-9760-5fb89c237620 61 fields · synced Jul 25, 2026