FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118607346
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
UB2TA8
Catalog number
UB2TA8
Device description
Urine Bag Adult, 2 L, T-Valve
Published
2023-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118611930PackageGS15000In Commercial Distribution
00840118615273PackageGS15In Commercial Distribution
00840118615280PackageGS110In Commercial Distribution
00840118607346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118611930008401186119308401186119300840118611930
00840118615273008401186152738401186152730840118615273
00840118615280008401186152808401186152800840118615280
00840118607346008401186073468401186073460840118607346

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius49 Degrees Celsius
Storage 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
00840118611930ENDURE INDUSTRIESENDURE INDUSTRIESEYZ2023-10-14
00610075105618HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075093469HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075096453HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075096552HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075105612HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
10080196028863MEDLINEMEDLINE INDUSTRIES, INC.EYZ2022-01-16
36641670005589SmartTap™ Paracentesis Drainage Bag, 4LCardiomed Supplies IncEYZ2020-11-27
36641670005626SmartTap™ Paracentesis Drainage Bag, 2LCardiomed Supplies IncEYZ2020-11-27
16641670005578SmartTap™ Paracentesis Drainage Bag, 4LCardiomed Supplies IncEYZ2020-11-27
16641670005615SmartTap™ Paracentesis Drainage Bag, 2LCardiomed Supplies IncEYZ2020-11-27
00810050241137N/ADOMICO MED-DEVICE, LLCEYZ2020-09-24
00810050242202N/ADOMICO MED-DEVICE, LLCEYZ2020-09-24
05055788767459EZ-Flow Catheter ValveFLEXICARE MEDICAL LIMITEDEYZ2020-03-25
20686864042956AMD-RITMEDAMD Medicom IncEYZ2019-01-24
20686864042963AMD-RITMEDAMD Medicom IncEYZ2019-01-24
10884521003446DoverCardinal Health, Inc.EYZ2018-06-27
10884521003453DoverCardinal Health, Inc.EYZ2018-06-27
20884521003443DoverCardinal Health, Inc.EYZ2018-06-27
20884521003450DoverCardinal Health, Inc.EYZ2018-06-27
10080196028856MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183012MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183401MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183418MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183531MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196028857MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196183013MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196183402MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196028825MedlineMEDLINE INDUSTRIES, INC.EYZ2016-09-29
10080196028894MedlineMEDLINE INDUSTRIES, INC.EYZ2016-09-29