FDA.reportPublic FDA data

BD PureHub

Primary DI
00382903065974
Brand
BD PureHub
Company
BECTON, DICKINSON AND COMPANY
Model
306597
Catalog number
306597
Device description
CAP DISINFECTION STRIP US
Published
2020-05-08
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
QBPCap, device disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBPCap, Device DisinfectantGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193190000BD PureHub Disinfecting CapBecton, Dickinson and Company2020-11-09QBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382903065975PackageGS1300In Commercial Distribution
50382903065979PackageGS115In Commercial Distribution
00382903065974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290306597530382903065975
5038290306597950382903065979
00382903065974003829030659743829030659740382903065974

GMDN Terms#

Term, Definition table
TermDefinition
Luer-formatted disinfection capA small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
001292192
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403523512HemoSphere AltaHEMA70CC2HEMA70CC22026-09-18
00885403523536HemoSphere AltaHEMAPSC200HEMAPSC2002026-09-18
00885403533122ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKBB64EKBB2026-09-18
00885403533146TruWave Reusable Cable64EKGE164EKGE12026-09-18
00885403533153ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKGE264EKGE22026-09-18
00885403533160TruWave Reusable Cable64EKH64EKH2026-09-18
00885403533610TruWave Reusable Cable70ANHS70ANHS2026-09-18
00885403533634Pressure Slave Cable70ANS70ANS2026-09-18
00885403533641Cable COO Catheter Interface70CC270CC22026-09-18
00885403533665TruWave Reusable CablePX15S162PX15S1622026-09-18
00885403533764Smart Pressure ControllerPC1QPC1Q2026-09-18
00885403533771Smart Pressure Controller Accessory KitPC1QAKPC1QAK2026-09-18
00885403543282TruWave Reusable CablePX12S162PX12S1622026-09-18
00885403543299TruWavePX17S162PX17S1622026-09-18
00885403543305TruWavePX21S162PX21S1622026-09-18
00885403543312TruWavePX6D162PX6D1622026-09-18
00885403543428TruWavePX6T162PX6T1622026-09-18
00885403543435TruWavePX2D162PX2D1622026-09-18
00885403543459TruWavePX11T162PX11T1622026-09-18
00885403543466TruWavePX7D162PX7D1622026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709097107SwabSleeve™ICU MEDICAL, INC.QBP2024-04-05
30887709097101SwabSleeve™ICU MEDICAL, INC.QBP2024-04-05
20612479261628McKessonMCKESSON MEDICAL-SURGICAL INC.QBP2022-11-10
20612479261642McKessonMCKESSON MEDICAL-SURGICAL INC.QBP2022-11-10
40612479261639McKessonMCKESSON MEDICAL-SURGICAL INC.QBP2022-11-10
30612479261656McKessonMCKESSON MEDICAL-SURGICAL INC.QBP2022-11-10
00887709097827SwabTip™ICU MEDICAL, INC.QBP2021-08-23
30887709097828SwabTip™ICU MEDICAL, INC.QBP2021-08-23
00887709082151SwabCap™ICU MEDICAL, INC.QBP2021-07-09
00887709082175SwabCap™ICU MEDICAL, INC.QBP2021-07-09
10887709082158SwabCap™ICU MEDICAL, INC.QBP2021-07-09
10887709082172SwabCap™ICU MEDICAL, INC.QBP2021-07-09
10884450309978DualCap®Merit Medical Systems, Inc.QBP2021-05-17
20884450309975DualCap®Merit Medical Systems, Inc.QBP2021-05-17
30382903065968BD PureHubBECTON, DICKINSON AND COMPANYQBP2020-05-08
50382903065962BD PureHubBECTON, DICKINSON AND COMPANYQBP2020-05-08
50382903065979BD PureHubBECTON, DICKINSON AND COMPANYQBP2020-05-08
10884450309459DualCap®Merit Medical Systems, Inc.QBP2020-01-06
20884450309456DualCap®Merit Medical Systems, Inc.QBP2020-01-06
10884450309428DualCap®Merit Medical Systems, Inc.QBP2019-01-16
20884450309425DualCap®Merit Medical Systems, Inc.QBP2019-01-16
10884450309367DualCap®Merit Medical Systems, Inc.QBP2018-09-28
10884450309374DualCap®Merit Medical Systems, Inc.QBP2018-09-28
10884450309411DualCap®Merit Medical Systems, Inc.QBP2018-09-28
20884450309364DualCap®Merit Medical Systems, Inc.QBP2018-09-28
20884450309371DualCap®Merit Medical Systems, Inc.QBP2018-09-28
20884450309418DualCap®Merit Medical Systems, Inc.QBP2018-09-28