FDA.reportPublic FDA data

McKesson

Primary DI
20612479195589
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
4654
Device description
Winged Infusion Set 21G
Published
2017-06-29
Public version status
Update
Distribution status
Not 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
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953252000DISPOSABLE SCALP VEIN INFUSION SETMyco Medical Supplies, Inc.1996-11-26FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479195590PackageGS120Not in Commercial Distribution
20612479195589PrimaryGS10
10612479195575Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247919559040612479195590
2061247919558920612479195589
1061247919557510612479195575

GMDN Terms#

Term, Definition table
TermDefinition
Scalp vein intravenous administration setA collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container into a patient's scalp vein. It typically includes tubing, connectors, chambers, clamps, and specialized needles to access scalp veins. The device is normally intended for use on paediatric patients, especially infants. This is a single-use device.

Regulatory Flags#

DUNS number
023904428
Device count
50
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
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902219210ARROWTELEFLEX INCORPORATEDFOZ2026-08-03
10801902130546ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218084ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218404ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902224436ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
00382903935314NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
10801902129700ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167351ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167894ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
10884521832930MAHURKARMozarc Medical US LLCFOZ2022-11-03
10884521832985MAHURKARMozarc Medical US LLCFOZ2022-11-03
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30