ENDURE INDUSTRIES

Primary DI
00840118613668
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
Rx
false
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6072994971support@endureind.com

Regulatory Flags#

DUNS number
066087031
Device count
1
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
true
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
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
00840118611596ENDURE 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