FDA.reportPublic FDA data

Navina™ Mini Set

Primary DI
07333387052823
Brand
Navina™ Mini Set
Company
Wellspect AB
Model
6930740
Catalog number
6930740
Device description
Navina Mini Set. 1 Water Container, 30 Rectal Cones. Non Sterile Device.
Published
2024-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCEEnema kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333387052823PackageGS11In Commercial Distribution
07333387052816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387052823073333870528237333387052823
07333387052816073333870528167333387052816

GMDN Terms#

Term, Definition table
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 nozzle/catheter to channel the water. It is intended for use in the home and healthcare facility. This is a reusable device.

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
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333387055695LoFric Elle Pro41910502026-05-20
07333387055725LoFric Elle Pro41912502026-05-20
07333387055756LoFric Elle Pro41914502026-05-20
07333387056623Surity Male External Catheter3802138021402026-04-27
07333387056630Surity Female External Catheter3801138011402025-12-19
07333387055329Surity Female External Catheter38011380112025-12-19
07333387053110LoFric® Origo™4491244912402025-11-24
07333387053127LoFric® Origo™4491444914402025-11-24
07333387053134LoFric® Origo™4491644916402025-11-24
07333387054537LoFric® Origo™4491244912402025-11-24
07333387054575LoFric® Origo™4491444914402025-11-24
07333387054605LoFric® Origo™4491644916402025-11-24
07333387052953LoFric® Origo™4471244712402025-07-25
07333387053059LoFric® Origo™4471444714402025-07-25
07333387053066LoFric® Origo™4471644716402025-07-25
07333387054353LoFric® Origo™4471244712402025-07-25
07333387054377LoFric® Origo™4471444714402025-07-25
07333387054421LoFric® Origo™4471644716402025-07-25
07333387002200LoFric® Origo™4451244512402024-08-25
07333387002217LoFric® Origo™4451444514402024-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEASSOMEDIKA, OOOFCE2026-05-26
16971919462528Medi GradeNingbo Albert Novosino Co.,Ltd.FCE2025-12-29
00661392042483LSL HEALTHCARELSL Industries, LLCFCE2025-10-30
00661392011649LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
10661392011646LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
00661392000902LSL HEALTHCARELSL Industries, LLCFCE2025-05-15
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
10192253028997DoverCardinal Health 200, LLCFCE2025-01-16
10192253029017DoverCardinal Health 200, LLCFCE2025-01-16
50192253028995DoverCardinal Health 200, LLCFCE2025-01-16
50192253029015DoverCardinal Health 200, LLCFCE2025-01-16
07333387024769Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052601Navina™ Classic System RefillWellspect ABFCE2025-01-10
07333387052625Navina™ Smart SystemWellspect ABFCE2025-01-10
07333387052564Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052779Navina Mini Refill SetWellspect ABFCE2024-10-28
07333387052816Navina™ Mini SetWellspect ABFCE2024-10-28
07333387052830Navina Mini Extension SetWellspect ABFCE2024-10-28
07333387052878Navina™ Mini Start SetWellspect ABFCE2024-10-28
07333387052854Navina Mini Refill 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
05055270979308RocketROCKET MEDICAL PLCFCE2023-10-24
05055270979322RocketROCKET MEDICAL PLCFCE2023-10-24
07333387029313Navina™ Classic System ConeWellspect ABFCE2023-09-25
07333387029702Navina™ Classic System Cone RefillWellspect ABFCE2023-09-25