FDA.reportPublic FDA data

Pediatric Urine Collector

Primary DI
00616784428314
Brand
Pediatric Urine Collector
Company
Dynarex Corporation
Model
4283
Device description
Pediatric Urine Collector, 200mL
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EXIDevice, Paste-On For Incontinence, Sterile
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXIDevice, Paste-On For Incontinence, SterileGastroenterology, Urology1
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784428321PackageGS150In Commercial Distribution
00616784428338PackageGS110In Commercial Distribution
00616784428314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784428321006167844283216167844283210616784428321
00616784428338006167844283386167844283380616784428338
00616784428314006167844283146167844283140616784428314

GMDN Terms#

Term, Definition table
TermDefinition
Wearable paediatric urine collection bagA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of a pre-adolescent paediatric patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840117311435Resp-O2 Nasal O2 Cannula Cushion Tip331552021-04-22
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00840117316423Resp-O2 Nasal O2 Cannula Cushion Tip331712021-04-22
00840117316430Resp-O2 Nasal O2 Cannula Cushion Tip331722021-04-22
00840117316447Resp-O2 Nasal O2 Cannula Cushion Tip331732021-04-22
00840117316454Resp-O2 Nasal O2 Cannula Cushion Tip331742021-04-22
00840117316461Nasal O2 Cannula Cushion Tip331752021-04-22
00840117316478Resp-O2 Nasal O2 Cannula Cushion Tip331762021-04-22
00840117316577Resp-O2 EtCO2 Nasal Sampling Cannula331802021-04-22
00840117316584Resp-O2 EtCO2 Nasal Sampling Cannula331812021-04-22
00840117316591Resp-O2 EtCO2 Nasal Sampling Cannula331822021-04-22
00840117316607Resp-O2 EtCO2 Nasal Sampling Cannula331832021-04-22
00840117316614Resp-O2 EtCO2 Nasal Sampling Cannula331842021-04-22
00840117316621Resp-O2 EtCO2 Nasal Sampling Cannula331852021-04-22
00840117316638Resp-O2 EtCO2 Nasal Sampling Cannula331862021-04-22
00840117316645Resp-O2 EtCO2 Nasal Sampling Cannulas331872021-04-22

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