FDA.report

Navina™ Catheter Set Small

Primary DI
07333387025087
Brand
Navina™ Catheter Set Small
Company
Wellspect AB
Model
68943
Catalog number
6894340
Device description
Navina Transanal Irrigation. Rectal Catheter set small. 10 Rectal catheters small. Single use. Non sterile Device. Rx Only.
Published
2023-09-01
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
true

Related Records

Contact Domains

Product Codes

CodeName
FCEEnema kit

Product Code Classifications

CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07333387025087PackageGS110In Commercial Distribution
07333387025094PackageGS13In Commercial Distribution
07392532243837PreviousGS10
07333387024752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07333387025087073333870250877333387025087
07333387025094073333870250947333387025094
07392532243837073925322438377392532243837
07333387024752073333870247527333387024752

GMDN Terms

TermDefinition
Rectal irrigation system catheterA flexible tube that is a component of a rectal irrigation system and designed to be inserted into the rectum (may be held in position by an inflatable retention balloon) where it serves as a conduit for water introduced into the rectum. The irrigation is typically used to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. This is a single-use 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
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEASSOMEDIKA, OOOFCE2026-05-26
16971919462528Medi GradeNingbo Albert Novosino Co.,Ltd.FCE2025-12-29
10661392011646LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
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
07333387025513Navina™Consumable Set SmallWellspect ABFCE2023-09-01
07333387027371Navina™ Smart System RegularWellspect ABFCE2023-09-01
07333387029023Navina™Consumable Set ConeDentsply Ih ABFCE2023-09-01
07333387030104Navina™ Smart System ConeWellspect ABFCE2023-08-30
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