FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118613675
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
PUC2A8
Catalog number
PUC2A8
Device description
Urine Collector, Pediatric 200 ml
Published
2024-04-10
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
00840118613682PackageGS1100In Commercial Distribution
00840118613675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118613682008401186136828401186136820840118613682
00840118613675008401186136758401186136750840118613675

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
00840118617567Endure IndustriesECLJBSECLJBS-302026-08-03
00840118617581Endure IndustriesECLJBMECLJBM2026-08-03
00840118617604Endure IndustriesECLJBLECLJBL2026-08-03
00840118617628Endure IndustriesECLJBXLECLJBXL2026-08-03
00840118617659ENDURE INDUSTRIESELCKSELCKS2026-08-03
00840118617673Endure IndustriesELCKMELCKM2026-08-03
00840118617697Endure IndustriesELCKLELCKL2026-08-03
00840118617710Endure IndustriesELCKXLELCKXL2026-08-03
00840118617741Endure IndustriesELCKXXLELCKXXL2026-08-03
00840118617772Endure IndustriesELCTSELCTS2026-08-03
00840118617802Endure IndustriesELCTMELCTM2026-08-03
00840118620444ENDURE INDUSTRIESGSTMGSTM2026-08-03
00840118620468ENDURE INDUSTRIESGSTLGSTL2026-08-03
00840118620482ENDURE INDUSTRIESGSTXGSTX2026-08-03
00840118687690Endure IndustriesELCTLELCTL2026-08-03
00840118698399Endure IndustriesELCTXLELCTXL2026-08-03
00840118608046ENDURE INDUSTRIESNROMA11NROMA112024-04-01
00840118608060ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10
00840118611633ENDURE INDUSTRIESNROMAE11NROMAE112024-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118613682ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-10
00840118611596ENDURE INDUSTRIESENDURE INDUSTRIESFFH2024-04-01
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