FDA.reportPublic FDA data

Transfix Continence Sheath

Primary DI
10801741072250
Brand
Transfix Continence Sheath
Company
C. R. Bard, Inc.
Model
TF23230
Catalog number
TF23230
Device description
Transfix All Silicone Self-Adhesive Continence Sheath
Published
2020-09-22
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
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
10801741072250PackageGS130In Commercial Distribution
20801741072257PackageGS1300In Commercial Distribution
00801741072253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107225010801741072250
2080174107225720801741072257
00801741072253008017410722538017410722530801741072253

GMDN Terms#

Term, Definition table
TermDefinition
Urinary incontinence penis sheath/port, single-use, non-sterileA non-sterile 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 Diameter32Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00801741011191N/A006172P006172P2015-06-29
00801741011207N/A006173P006173P2015-06-29
00801741011214N/A006221P006221P2015-06-29
00801741011221N/A006225P006225P2015-06-29
00801741011238N/A006241P006241P2015-06-29
00801741011245N/A006242P006242P2015-06-29
00801741011269NBIH™ Temporary Pacing Electrode Catheter007150P007150P2015-06-29
00801741011276NBIH™ Temporary Pacing Electrode Catheter007151P007151P2015-06-29
00801741011283NBIH™ Temporary Pacing Electrode Catheter007152P007152P2015-06-29
00801741011290NBIH™ Temporary Pacing Electrode Catheter007153P007153P2015-06-29
00801741011306GOETZ™ Temporary Pacing Electrode Catheter007154P007154P2015-06-29
00801741011313GOETZ™ Temporary Pacing Electrode Catheter007155P007155P2015-06-29
00801741011320GOETZ™ Temporary Pacing Electrode Catheter007156P007156P2015-06-29
00801741011337GOETZ™ Temporary Pacing Electrode Catheter007157P007157P2015-06-29
00801741011344NBIH™ Temporary Pacing Electrode Catheter007250P007250P2015-06-29
00801741011351NBIH™ Temporary Pacing Electrode Catheter007253P007253P2015-06-29
00801741011368NBIH™ Temporary Pacing Electrode Catheter007406P007406P2015-06-29
00801741011375NBIH™ Temporary Pacing Electrode Catheter007417P007417P2015-06-29
00801741011474NBIH™ Temporary Pacing Electrode Catheter057152P057152P2015-06-29
00801741011481NBIH™ Temporary Pacing Electrode Catheter057153P057153P2015-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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