PEDIATRIC URINE COLLECTORS, STERILE

Primary DI
10687225793596
Brand
PEDIATRIC URINE COLLECTORS, STERILE
Company
PRECISION DYNAMICS CORPORATION
Model
05002
Catalog number
05002-00-SSB (Y5178898)
Device description
PEDIATRIC URINE COLLECTORS, STERILE, 100/Box, 500/Case
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
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
10687225793596PackageGS1500In Commercial Distribution
10687225793756PrimaryGS10
10687225794708Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068722579359610687225793596
1068722579375610687225793756
1068722579470810687225794708

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008486367
Device count
100
DM exempt
false
Premarket exempt
true
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
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
00616784428314Pediatric Urine CollectorDynarex CorporationEXI2021-06-21
10612479188713McKessonMCKESSON MEDICAL-SURGICAL INC.EXI2020-06-25
20612479188727McKessonMCKESSON MEDICAL-SURGICAL INC.EXI2020-06-25
10704411008040AMSureĀ® Pediatric Urine CollectorAMSINO INTERNATIONAL, INC.EXI2018-06-01
10704411008057AMSureĀ® Pediatric Urine CollectorAMSINO INTERNATIONAL, INC.EXI2018-06-01
10687225301852UR-Assure PRECISION DYNAMICS CORPORATIONEXI2017-10-25