FDA.report

Navina™ Classic System Small Refill

Primary DI
07333387026985
Brand
Navina™ Classic System Small Refill
Company
Wellspect AB
Model
69008
Catalog number
6900840
Device description
Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters small, Non Sterile Device. Rx Only.
Published
2023-09-21
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
07333387026985PackageGS13In Commercial Distribution
07392532243738PreviousGS10
07333387026978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07333387026985073333870269857333387026985
07392532243738073925322437387392532243738
07333387026978073333870269787333387026978

GMDN Terms

TermDefinition
Manual rectal irrigation systemA portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. It typically consists of a control unit that regulates the air/water balance and includes a manually-operated hand pump to propel the water, a container for the water (e.g., a plastic bag), and a rectal catheter to channel the water. 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

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07333387054353LoFric® Origo™4471244712402025-07-25
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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
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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
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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
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