FDA.report

Navina™ Smart System Cone

Primary DI
07333387030104
Brand
Navina™ Smart System Cone
Company
Wellspect AB
Model
69019
Catalog number
6901940
Device description
Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 2 Rectal catheters cone, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only.
Published
2023-08-30
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

Related Records

Contact Domains

Product Codes

CodeName
FCEEnema kit

Product Code Classifications

CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07333387030104PackageGS11In Commercial Distribution
07392532243981PreviousGS10
07333387030098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07333387030104073333870301047333387030104
07392532243981073925322439817392532243981
07333387030098073333870300987333387030098

GMDN Terms

TermDefinition
Powered rectal/colostomy irrigation systemA portable assembly of battery-powered devices intended to be used by, or on a patient, for the controlled introduction of a non-medicated solution (typically water) into the rectum to treat faecal incontinence or constipation (rectal irrigation), and/or for colostomy site irrigation; it is not intended for irrigation of the entire colon. It consists of a reservoir, an electronic pump/control unit, connection tubing, and may include patient contact devices (e.g., rectal irrigation system catheter, colostomy irrigation tip), and a battery charging device (e.g., mains power lead). It is intended for use in the home and healthcare facility. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature.

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
07333387055329Surity Female External Catheter38011380112025-12-19
07333387054537LoFric® Origo™4491244912402025-11-24
07333387054575LoFric® Origo™4491444914402025-11-24
07333387054605LoFric® Origo™4491644916402025-11-24
07333387054353LoFric® Origo™4471244712402025-07-25
07333387054377LoFric® Origo™4471444714402025-07-25
07333387054421LoFric® Origo™4471644716402025-07-25
07333387052564Navina™ Catheter Set Cone6894668946402025-01-10
07333387052595Navina™ Classic System Regular6910569105402025-01-10
07333387052618Navina™ Classic System Refill6910669106402025-01-10
07333387052632Navina™ Smart System6910969109402025-01-10
07333387052854Navina Mini Refill Set693094069309402024-10-28
07333387052823Navina™ Mini Set693074069307402024-10-28
07333387052847Navina Mini Extension Set693084069308402024-10-28
07333387052885Navina™ Mini Start Set693104069310402024-10-28
07333387008769LoFric® Origo™4451244512402024-08-25
07333387009193LoFric® Origo™4451444514402024-08-25
07333387043685SimPro™ Set530100053010002024-05-02
07333387043753SimPro™ Set530140053014002024-05-02
07333387043869SimPro™ Set535140053514002024-05-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16971919462528Medi GradeNingbo Albert Novosino Co.,Ltd.FCE2025-12-29
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10661392000909LSL HEALTHCARELSL Industries, LLCFCE2025-05-15
10827989007694Health Care Logistics, Inc®Health Care Logistics, Inc.FCE2025-03-13
10827989007700Health Care Logistics, Inc®Health Care Logistics, Inc.FCE2025-03-13
50192253028995DoverCardinal Health 200, LLCFCE2025-01-16
50192253029015DoverCardinal Health 200, LLCFCE2025-01-16
07333387052564Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052854Navina Mini Refill SetWellspect ABFCE2024-10-28
07333387052823Navina™ Mini SetWellspect ABFCE2024-10-28
07333387052847Navina Mini Extension SetWellspect ABFCE2024-10-28
07333387052885Navina™ Mini Start SetWellspect ABFCE2024-10-28
06971919461395PREMIUMNingbo Albert Novosino Co.,Ltd.FCE2024-03-11
06971919461401PREMIUMNingbo Albert Novosino Co.,Ltd.FCE2024-03-11
05055270979322RocketROCKET MEDICAL PLCFCE2023-10-24
07333387029719Navina™ Classic System Cone RefillWellspect ABFCE2023-09-25
07333387026985Navina™ Classic System Small RefillWellspect ABFCE2023-09-21
07333387025087Navina™ Catheter Set SmallWellspect ABFCE2023-09-01
07333387025513Navina™Consumable Set SmallWellspect ABFCE2023-09-01
07333387027371Navina™ Smart System RegularWellspect ABFCE2023-09-01
07333387029023Navina™Consumable Set ConeDentsply Ih ABFCE2023-09-01
07333387027739Navina™ Smart System SmallWellspect ABFCE2023-08-23
07333387028736Navina™ Smart Control Unit Wellspect ABFCE2023-01-19
06971919469056NoneNingbo Albert Novosino Co.,Ltd.FCE2022-11-18
50192253013748DoverCardinal Health 200, LLCFCE2022-11-08
50192253013755DoverCardinal Health 200, LLCFCE2022-11-08
00616784471136Cleansing Enema SetDYNAREX CORPORATIONFCE2021-06-21
07392532243905Navina™Consumable Set ConeWellspect ABFCE2019-12-19
07392532243929Navina™ Smart System RegularWellspect ABFCE2019-12-19
07392532243950Navina™ Smart System SmallWellspect ABFCE2019-12-19