FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118611596
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
PUC1A8
Catalog number
PUC1A8
Device description
Urine Collector, Pediatric 100 ml
Published
2024-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFHCollector, Urine, Pediatric, For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFHCollector, Urine, Pediatric, For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118613668PackageGS1100In Commercial Distribution
00840118611596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118613668008401186136688401186136680840118613668
00840118611596008401186115968401186115960840118611596

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius49 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
6072994971support@endureind.com

Regulatory Flags#

DUNS number
066087031
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
Primary DIBrandModelCatalogPublished
00840118621137Endure IndustriesOMEP11OMEP112026-08-17
00840118600361Endure IndustriesNDAFC211NDAFC2112026-08-14
00840118602150Endure IndustriesECAKCDQ-118ECAKCDQ-1182026-08-14
00840118607988Endure IndustriesNCAC211NCAC2112026-08-14
00840118609616Endure IndustriesNDAMC211NDAMC2112026-08-14
00840118614245Endure IndustriesESP38ESP382026-08-14
00840118614252Endure IndustriesESP310ESP3102026-08-14
00840118614269Endure IndustriesESP511ESP5112026-08-14
00840118614276Endure IndustriesESP516ESP5162026-08-14
00840118614283Endure IndustriesESP713ESP7132026-08-14
00840118614290Endure IndustriesESP916ESP9162026-08-14
00840118614306Endure IndustriesESP1118ESP11182026-08-14
00840118614900Endure IndustriesNDAF211NDAF2112026-08-14
00840118616447Endure IndustriesEBSEBS2026-08-14
00840118617338Endure IndustriesNDAM411UNDAM411U2026-08-14
00840118617352Endure IndustriesNDAM411NDAM4112026-08-14
00840118617376Endure IndustriesNDAF411UNDAF411U2026-08-14
00840118617390Endure IndustriesNDAF411NDAF4112026-08-14
00840118617413Endure IndustriesNCPC211NCPC2112026-08-14
00840118617437Endure IndustriesNDPM211NDPM2112026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118613675ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-10
00840118613682ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-10
00840118613668ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-01
00827002179394CookCOOK INCORPORATEDFFH2017-08-09
00801741045820Davol® Female Cath KitC. R. Bard, Inc.FFH2016-09-06
00801741045837Davol® Female Cath KitC. R. Bard, Inc.FFH2016-09-06
00801741045844Davol® Infant Cath KitC. R. Bard, Inc.FFH2016-09-06
00801741045851Davol® Pediatric Cath KitC. R. Bard, Inc.FFH2016-09-06
20801741045824Davol® Female Cath KitC. R. Bard, Inc.FFH2016-09-06
10801741045834Davol® Female Cath KitC. R. Bard, Inc.FFH2016-09-06
10801741045841Davol® Infant Cath KitC. R. Bard, Inc.FFH2016-09-06
10801741045858Davol® Pediatric Cath KitC. R. Bard, Inc.FFH2016-09-06