Coloplast

Primary DI
00762123032299
Brand
Coloplast
Company
Coloplast A/S
Model
21365
Catalog number
21365
Published
2022-12-05
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
NNWBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00762123032299PackageGS110In Commercial Distribution
00762123032282PrimaryGS10
05701780055567Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123032299007621230322997621230322990762123032299
00762123032282007621230322827621230322820762123032282
05701780055567057017800555675701780055567

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
Length120Centimeter
Total Volume2000Milliliter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305524696
Device count
10
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

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Primary DI, Brand, Company table
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10860012266811Acosta Uro-GardAcosta Medical Group, Inc.NNW2025-02-19
10618125191182TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
00618125191185TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
15060797553860NADavid Scott CompanyNNW2023-07-26
00615521015336ALLENHILL-ROM, INC.NNW2023-05-26
00615521015350ALLENHILL-ROM, INC.NNW2023-05-26
00615521015367ALLENHILL-ROM, INC.NNW2023-05-26
00615521019990ALLENHILL-ROM, INC.NNW2023-05-26
00615521020002ALLENHILL-ROM, INC.NNW2023-05-26
00615521020019ALLENHILL-ROM, INC.NNW2023-05-26
00615521020606ALLENHILL-ROM, INC.NNW2023-05-26
00615521020675ALLENHILL-ROM, INC.NNW2023-05-26
05708932135184ConveenColoplast A/SNNW2023-01-17
00762123017197ConveenColoplast A/SNNW2023-01-17
15060797553600NADavid Scott CompanyNNW2023-01-09
10810087350489CoulmedCoulmed Products Group LLCNNW2023-01-06
10810087350502CoulmedCoulmed Products Group LLCNNW2023-01-06
00762123032282ColoplastColoplast A/SNNW2022-12-05
05708932640312ConveenColoplast A/SNNW2022-12-02
05708932732420Conveen StandardColoplast A/SNNW2022-12-02
05708932640329ConveenColoplast A/SNNW2022-12-02
00762123002094Conveen StandardColoplast A/SNNW2022-12-02
00610075093427HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093434HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093489HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093496HollisterHOLLISTER INCORPORATEDNNW2022-12-01
20610075093421HollisterHOLLISTER INCORPORATEDNNW2022-12-01
20610075093438HollisterHOLLISTER INCORPORATEDNNW2022-12-01
20610075093452HollisterHOLLISTER INCORPORATEDNNW2022-12-01