FDA.reportPublic FDA data

UR-Assure

Primary DI
10687225301852
Brand
UR-Assure
Company
PRECISION DYNAMICS CORPORATION
Model
05002-00-MCF
Device description
Pediatric Urine Collectors, Sterile, 160MIL
Published
2017-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10687225301852PrimaryGS10
80687225301851Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068722530185210687225301852
8068722530185180687225301851

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive infant/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/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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008486367
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10687225799024DuraholderY5647877PDC-DURA100/1002024-01-16
10687225799031DuraholderY5647878PDC-DURA102/1002024-01-16
10687225799048DuraholderY5647879PDC-DURA300/1002024-01-16
10687225799062DuraholderY5647881PDC-DURA505/1002024-01-16
10687225799079DuraholderY5647882PDC-DURA512/1002024-01-16
10687225799086DuraholderY5647883PDC-DURA702/1002024-01-16
10687225325087Gantry GuardCTG012016-07-28
10687225488560Gantry GuardSCTG012016-07-28
10687225648889Gantry Guard FlexCTG02CTG022018-04-25
10687225677865Gantry Guard Flex MiniCTG03CTG032018-04-25
10687225704615Gantry Guard FlexPSCTCVR22019-01-08
10687225704622Gantry Guard Flex MiniPSCTCVR32019-01-08
10687225799185DuraholderY5647877PDC-DURA100/1002024-01-16
10687225799192DuraholderY5647878PDC-DURA102/1002024-01-16
10687225799208DuraholderY5647879PDC-DURA300/1002024-01-16
10687225799222DuraholderY5647881PDC-DURA505/1002024-01-16
10687225799239DuraholderY5647882PDC-DURA512/1002024-01-16
10687225799246DuraholderY5647883PDC-DURA702/1002024-01-16
10687225793756PEDIATRIC URINE COLLECTORS, STERILE0500205002-00-SSB (Y5178898)2023-06-20
10687225793749PEDIATRIC URINE COLLECTORS, CLEAN0500105001-00-SCB (Y5178897)2023-06-20

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
10612479188713McKessonMCKESSON MEDICAL-SURGICAL INC.EXI2020-06-25
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