FDA.reportPublic FDA data

Navina™ Classic System Regular

Primary DI
07333387052588
Brand
Navina™ Classic System Regular
Company
Wellspect AB
Model
69105
Catalog number
6910540
Device description
Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. 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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333387052595PackageGS11In Commercial Distribution
07333387052588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387052595073333870525957333387052595
07333387052588073333870525887333387052588

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
No natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012354KangarooCardinal Health 200, LLCKNT2025-07-11
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071132163MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132170MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132187MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132194MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071121105MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121112MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121129MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121136MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121143MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121150MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121167MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121174MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121181MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121198MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121204MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121211MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121228MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121235MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121242MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121259MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121266MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11