FDA.reportPublic FDA data

BD Vacutainer® UltraTouch™ Push Button Blood Collection Set

Primary DI
30382903673644
Brand
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set
Company
BECTON, DICKINSON AND COMPANY
Model
367364
Catalog number
367364
Device description
WINGSET PBBCS UTW PP 23X.75 12 LUER
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212724000BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company2022-02-04JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903673648PackageGS14In Commercial Distribution
30382903673644PrimaryGS10
00382903673643Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290367364850382903673648
3038290367364430382903673644
00382903673643003829036736433829036736430382903673643

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection TubeBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666172BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached HolderBECTON, DICKINSON AND COMPANYJKA2024-03-25
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGJKA2024-02-20
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGJKA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGJKA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGJKA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06