FDA.reportPublic FDA data

Conveen Standard

Primary DI
00762123002094
Brand
Conveen Standard
Company
Coloplast A/S
Model
05062
Catalog number
05062
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNWBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00762123002018PackageGS110In Commercial Distribution
00762123002094PackageGS16In Commercial Distribution
05708932732420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123002018007621230020187621230020180762123002018
00762123002094007621230020947621230020940762123002094
05708932732420057089327324205708932732420

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Inch
Length90Centimeter
Total Volume51Fluid Ounce
Total Volume1500Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged and consult IFU.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08
05701780385633SenSura Mio Convex18548185482026-06-08
05701780385664SenSura Mio Convex18549185492026-06-08
05701780385701SenSura Mio Convex18550185502026-06-08
05701780385732SenSura Mio Convex18551185512026-06-08
05701780385763SenSura Mio Convex18540185402026-06-08
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10618125191182TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
10810087350489CoulmedCoulmed Products Group LLCNNW2023-01-06
10810087350502CoulmedCoulmed Products Group LLCNNW2023-01-06
00762123056028Conveen Security+Coloplast A/SNNX2022-12-06
00762123056042Conveen Security+Coloplast A/SNNX2022-12-06
00762123056066Conveen Security+Coloplast A/SNNX2022-12-06
00762123056080Conveen Security+Coloplast A/SNNX2022-12-06
00762123032282ColoplastColoplast A/SNNW2022-12-05
00762123056004Conveen Security+Coloplast A/SNNX2022-12-02
00762123056011Conveen Security+Coloplast A/SNNX2022-12-02
00762123056035Conveen Security+Coloplast A/SNNX2022-12-02
00762123056059Conveen Security+Coloplast A/SNNX2022-12-02
00762123056073Conveen Security+Coloplast A/SNNX2022-12-02
10610075154644EverydayHOLLISTER INCORPORATEDNNX2022-12-01
10610075154651EverydayHOLLISTER INCORPORATEDNNX2022-12-01
10610075154668EverydayHOLLISTER INCORPORATEDNNX2022-12-01
10610075154675EverydayHOLLISTER INCORPORATEDNNX2022-12-01
10610075154828Extended WearHOLLISTER INCORPORATEDNNX2022-12-01
10610075154835Extended WearHOLLISTER INCORPORATEDNNX2022-12-01
10610075154842Extended WearHOLLISTER INCORPORATEDNNX2022-12-01
10610075154859Extended WearHOLLISTER INCORPORATEDNNX2022-12-01
00610075093427HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093434HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093489HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093496HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075205790InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205806InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205813InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205820InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205837InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01