Self-Cath

Primary DI
05708932286534
Brand
Self-Cath
Company
Coloplast A/S
Model
475/50785
Catalog number
475/50785
Published
2022-12-02
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

Related Records

Product Codes

CodeName
NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708932286527PackageGS112In Commercial Distribution
05708932286534PackageGS130In Commercial Distribution
05708932957656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708932286527057089322865275708932286527
05708932286534057089322865345708932286534
05708932957656057089329576565708932957656

GMDN Terms

TermDefinition
Urine drainage extension tubingA length of noninvasive flexible tubing intended to connect between a patient contact urinary drainage device (e.g., urethral catheter, urostomy pouch) and a receptacle; some types may in addition be intended for extra-urinary passive drainage applications (e.g., intestinal ostomy or wound drainage). It is typically self-applied; it does not include a valve or clamp (i.e., not a tubing set). This is a single-use device.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
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
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
05708932282215Freedom ClearColoplast A/SNNX2022-12-06
05708932282116Freedom ClearColoplast A/SNNX2022-12-06
05708932282260Freedom ClearColoplast A/SNNX2022-12-06
05708932535939Conveen OptimaColoplast A/SNNX2022-12-06
05708932851299Conveen OptimaColoplast A/SNNX2022-12-06
05708932535953Conveen OptimaColoplast A/SNNX2022-12-06
05708932535984Conveen OptimaColoplast A/SNNX2022-12-06
00762123052433Conveen OptimaColoplast A/SNNX2022-12-06
05708932285292Freedom Active CathColoplast A/SNNX2022-12-06
05708932285124Freedom Active CathColoplast A/SNNX2022-12-06
05708932283489Freedom Active CathColoplast A/SNNX2022-12-06
05708932299503Freedom Active CathColoplast A/SNNX2022-12-06
05708932285186Freedom CathColoplast A/SNNX2022-12-06
05708932285063Freedom CathColoplast A/SNNX2022-12-06