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
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012266807Acosta Uro-GardAcosta Medical Group, Inc.NNW2025-02-19
10860012266811Acosta Uro-GardAcosta Medical Group, Inc.NNW2025-02-19
00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301284Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301314Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301352Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301406Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mmUROCARE PRODUCTS, INC.NNX2025-01-01
00618125191185TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
15060797553860NADavid Scott CompanyNNW2023-07-26
00615521015336ALLENALLEN MEDICAL SYSTEMS, INC.NNW2023-05-26
00615521015350ALLENALLEN MEDICAL SYSTEMS, INC.NNW2023-05-26
00615521015367ALLENALLEN MEDICAL SYSTEMS, INC.NNW2023-05-26
00615521019990ALLENALLEN MEDICAL SYSTEMS, INC.NNW2023-05-26
00615521020002ALLENALLEN MEDICAL SYSTEMS, INC.NNW2023-05-26
00615521020019ALLENALLEN MEDICAL SYSTEMS, INC.NNW2023-05-26
00615521020606ALLENALLEN MEDICAL SYSTEMS, INC.NNW2023-05-26
00615521020675ALLENALLEN MEDICAL SYSTEMS, INC.NNW2023-05-26
00762123017197ConveenColoplast A/SNNW2023-01-17
15060797553600NADavid Scott CompanyNNW2023-01-09
00762123001660Conveen Security+Coloplast A/SNNX2022-12-06
00762123001677Conveen Security+Coloplast A/SNNX2022-12-06
00762123001684Conveen Security+Coloplast A/SNNX2022-12-06
00762123017876Conveen Security+Coloplast A/SNNX2022-12-06
05708932283304Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932283267Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932283342Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932283380Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932283410Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932282246Freedom ClearColoplast A/SNNX2022-12-06
05708932282017Freedom ClearColoplast A/SNNX2022-12-06