FDA.reportPublic FDA data

Conveen Security+

Primary DI
00762123001653
Brand
Conveen Security+
Company
Coloplast A/S
Model
05235
Catalog number
05235
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

Product Codes#

Code, Name table
CodeName
NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00762123001547PackageGS135In Commercial Distribution
00762123001653PackageGS16In Commercial Distribution
00762123056059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123001547007621230015477621230015470762123001547
00762123001653007621230016537621230016530762123001653
00762123056059007621230560597621230560590762123056059

GMDN Terms#

Term, Definition table
TermDefinition
Urinary incontinence penis sheath/port, single-useA device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter35Millimeter

Sterilization Methods#

Method table
Method

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
true
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
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
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
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
00610075205844InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205851InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205868InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205875InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205882InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205899InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01
00610075205905InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01
00610075205912InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01