FDA.reportPublic FDA data

McKesson

Primary DI
10612479188713
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
4821
Device description
Pediatric Urine Collector, ST
Published
2020-06-25
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
EXIDevice, Paste-On For Incontinence, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXIDevice, Paste-On For Incontinence, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479188727PackageGS150In Commercial Distribution
40612479188738PackageGS120In Commercial Distribution
10612479188713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247918872720612479188727
4061247918873840612479188738
1061247918871310612479188713

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive paediatric urine collection bag, open-endedA flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/pre-adolescent paediatric patient. It is designed with an opening for urine drainage and is typically used for urine output measurement. This is a single-use device.

Regulatory Flags#

DUNS number
023904428
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

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
10687225793756PEDIATRIC URINE COLLECTORS, STERILEPRECISION DYNAMICS CORPORATIONEXI2023-06-20
10687225793596PEDIATRIC URINE COLLECTORS, STERILEPRECISION DYNAMICS CORPORATIONEXI2023-06-20
00616784428314Pediatric Urine CollectorDynarex CorporationEXI2021-06-21
20612479188727McKessonMCKESSON MEDICAL-SURGICAL INC.EXI2020-06-25
10704411008040AMSure® Pediatric Urine CollectorAMSINO INTERNATIONAL, INC.EXI2018-06-01
10704411008057AMSure® Pediatric Urine CollectorAMSINO INTERNATIONAL, INC.EXI2018-06-01
10687225301852UR-Assure PRECISION DYNAMICS CORPORATIONEXI2017-10-25