FDA.reportPublic FDA data

Navina™ Catheter Set Cone

Primary DI
07333387024769
Brand
Navina™ Catheter Set Cone
Company
Wellspect AB
Model
68946
Catalog number
6894640
Device description
Navina Transanal Irrigation. Rectal Catheter set cone. 10 Rectal catheters cone. Single use. Non sterile Device. Rx Only.
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCEEnema kit
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333387052564PackageGS110In Commercial Distribution
07333387052571PackageGS13In Commercial Distribution
07333387024769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387052564073333870525647333387052564
07333387052571073333870525717333387052571
07333387024769073333870247697333387024769

GMDN Terms#

Term, Definition table
TermDefinition
Rectal irrigation kitA collection of devices that includes a rectal irrigation nozzle (also known as a catheter) intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation; it is not intended for colostomy site irrigation or irrigation of the entire colon. In addition to the disposable nozzle, it includes a reusable fluid container (e.g., water bag). It is intended for use in the home and healthcare facility. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature.

Contacts#

Phone, Email table
PhoneEmail
+1(877)456-3742info-lofric-usa@wellspect.com

Regulatory Flags#

DUNS number
351118942
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333387059730LoFric Origo4401244012002026-08-28
07333387059754LoFric Origo4401444014002026-08-28
07333387059778LoFric Origo4401644016002026-08-28
07333387060446Surity Power Adapter380394038039402026-09-28
07333387055299Surity Urinary Management System380014038001402026-08-18
07333387055305Surity Urinary Management Refresh Kit380024038002402026-08-18
07333387059198Surity Urinary Management System with Battery380034038003402026-08-18
07333387055367Surity Suction Tube380314038031402026-07-13
07333387055398Surity Carbon Filters380344038034402026-07-13
07333387055695LoFric Elle Pro41910502026-05-20
07333387055725LoFric Elle Pro41912502026-05-20
07333387055756LoFric Elle Pro41914502026-05-20
07333387056623Surity Male External Catheter3802138021402026-04-27
07333387056630Surity Female External Catheter3801138011402025-12-19
07333387055329Surity Female External Catheter38011380112025-12-19
07333387053110LoFric® Origo™4491244912402025-11-24
07333387053127LoFric® Origo™4491444914402025-11-24
07333387053134LoFric® Origo™4491644916402025-11-24
07333387054537LoFric® Origo™4491244912402025-11-24
07333387054575LoFric® Origo™4491444914402025-11-24

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