FDA.reportPublic FDA data

Navina™ Smart System

Primary DI
07333387052632
Brand
Navina™ Smart System
Company
Wellspect AB
Model
69109
Catalog number
6910940
Device description
Navina Smart Transanal Irrigation. 1 Navina Smart 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
OTC
false
Sterile
false
Single use
false

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
07333387052632PackageGS11In Commercial Distribution
07333387052625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387052632073333870526327333387052632
07333387052625073333870526257333387052625

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
351118942
Device count
1
DM exempt
false
Premarket exempt
false
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
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