FDA.reportPublic FDA data

Navina™ Smart control unit with power adapter and cable

Primary DI
07392532244018
Brand
Navina™ Smart control unit with power adapter and cable
Company
Wellspect AB
Model
69014
Catalog number
6901440
Device description
Navina Smart Transanal Irrigation. 1 Navina Smart control unit with power adapter and cable. Non Sterile Device. Rx Only.
Published
2019-12-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07392532244018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532244018073925322440187392532244018

GMDN Terms#

Term, Definition table
TermDefinition
Powered rectal irrigation system control unitA portable, battery-powered regulator that is a component of a rectal irrigation system and designed to create the pressure required to propel the irrigation water into the rectum. It includes a pump and regulating device (e.g., a valve) intended to control the air/water balance of the system. 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; it is not intended for irrigation of the entire colon. This is a reusable device.

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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07333387056623Surity Male External Catheter3802138021402026-04-27
07333387056630Surity Female External Catheter3801138011402025-12-19
07333387055329Surity Female External Catheter38011380112025-12-19
07333387053110LoFric® Origo™4491244912402025-11-24
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07333387052953LoFric® Origo™4471244712402025-07-25
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07333387054353LoFric® Origo™4471244712402025-07-25
07333387054377LoFric® Origo™4471444714402025-07-25
07333387054421LoFric® Origo™4471644716402025-07-25
07333387002200LoFric® Origo™4451244512402024-08-25
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Primary DI, Brand, Company table
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10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
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10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
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