Freedom Cath

Primary DI
05708932283441
Brand
Freedom Cath
Company
Coloplast A/S
Model
8000/5061101400
Catalog number
8000/5061101400
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
05708932283441PackageGS1100In Commercial Distribution
05708932957823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708932283441057089322834415708932283441
05708932957823057089329578235708932957823

GMDN Terms

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

TypeValueUnit
Lumen/Inner Diameter0.9Inch
Lumen/Inner Diameter23Millimeter

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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