McKesson

Primary DI
30612479261656
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
421-SCXT3-10-2000
Device description
Cap, Disinfecting for Needle Free Valves, Strip of 10
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K130975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130975000SWABCAP AND SWABFLUSHExcelsior Medical Corp.2013-12-24QBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30612479261656PackageGS125In Commercial Distribution
40612479261660PackageGS18In Commercial Distribution
20612479261642PrimaryGS10
10612479265858Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061247926165630612479261656
4061247926166040612479261660
2061247926164220612479261642
1061247926585810612479265858

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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
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
00382903065974BD PureHubBECTON, DICKINSON AND COMPANYQBP2020-05-08
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