FDA.report

Navina™ Smart Control Unit

Primary DI
07333387028736
Brand
Navina™ Smart Control Unit
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
2023-01-19
Public version status
Update
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
07333387028736PackageGS11In Commercial Distribution
07392532244018PreviousGS10
07333387028729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07333387028736073333870287367333387028736
07392532244018073925322440187392532244018
07333387028729073333870287297333387028729

GMDN Terms

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

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
false
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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