FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118611930
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
Rx
false
OTC
true
Sterile
false
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

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
00840118613958ENDURE INDUSTRIESNDAM211NDAM2112026-05-01
08697645018129ENDURE INDUSTRIESAMT4MAMT4M2026-04-17
08697645018136ENDURE INDUSTRIESAMT5M2026-04-17
08697645018143ENDURE INDUSTRIESAMT6MAMT6M2026-04-17
08697645018150ENDURE INDUSTRIESBGE7MBGE7M2026-04-17
08697645018167ENDURE INDUSTRIESBGE9MBGE9M2026-04-17
08697645018174ENDURE INDUSTRIESBGA7MBGA7M2026-04-17
08697645018181ENDURE INDUSTRIESBGA9M BGA9M 2026-04-17
08697645018198ENDURE INDUSTRIESBB1MBB1M2026-04-17
00840118603676EndureSLL1A3-0520SLL1A32021-04-06
00840118603706EndureSLL2A3-0520SLL2A32020-08-31
00840118603737EndureSLL3A3-0520SLL3A32021-07-25
00840118603768EndureSLL5A3-0520SLL5A32020-08-31
00840118603799EndureSLL10A3-0520SLL10A32020-08-31
00840118603829EndureSLL20A3-0520SLL20A32020-08-31
00840118603850EndureSLL50A3-0520SLL50A32020-08-31
00840118603881EndureSLS1A3-0520SLS1A32020-09-15
00840118603911EndureSLS2A3-0520SLS2A32020-09-15
00840118603942EndureSLS3A3-0520SLS3A32020-09-15
00840118603973EndureSLS5A3-0520SLS5A32020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118607346ENDURE INDUSTRIESENDURE INDUSTRIESEYZ2023-10-14
00610075096459HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
00610075096558HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
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