FDA.report

Navina™Consumable Set Small

Primary DI
07333387025513
Brand
Navina™Consumable Set Small
Company
Wellspect AB
Model
69004
Catalog number
6900440
Device description
Navina Transanal Irrigation. Consumable set small. 1 Water container, 15 Rectal catheters small. 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
false

Related Records

Contact Domains

Product Codes

CodeName
FCEEnema kit

Product Code Classifications

CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07333387025513PackageGS13In Commercial Distribution
07392532243868PreviousGS10
07333387025506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07333387025513073333870255137333387025513
07392532243868073925322438687392532243868
07333387025506073333870255067333387025506

GMDN Terms

TermDefinition
Rectal irrigation kitA collection of non-sterile devices intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation; it is not intended for colostomy site irrigation or irrigation of the entire colon. It includes a rectal catheter and additional non-powered rectal irrigation devices (e.g., fluid container) which may include a single-use device(s). 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

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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

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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
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07333387027371Navina™ Smart System RegularWellspect ABFCE2023-09-01
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