Navina Mini Extension Set 6930840

GUDID 07333387052847

Navina Mini Extension Set. 1 Water Container, 30 Rectal Cones. 1 extension tube. Non Sterile Device.

Wellspect AB

Manual rectal irrigation system
Primary Device ID07333387052847
NIH Device Record Key303e2047-bf93-4cee-931e-60c945d5e0b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavina Mini Extension Set
Version Model Number6930840
Catalog Number6930840
Company DUNS351118942
Company NameWellspect AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107333387052830 [Primary]
GS107333387052847 [Package]
Contains: 07333387052830
Package: [1 Units]
In Commercial Distribution

FDA Product Code

FCEEnema kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-05
Device Publish Date2024-10-28

Devices Manufactured by Wellspect AB

07333387052564 - Navina™ Catheter Set Cone2025-01-20 Navina Transanal Irrigation. Rectal Catheter set cone. 10 Rectal catheters cone. Single use. Non sterile Device. Rx Only.
07333387052595 - Navina™ Classic System Regular2025-01-20 Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina cas
07333387052618 - Navina™ Classic System Refill2025-01-20 Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, Non Sterile Device. Rx Only.
07333387052632 - Navina™ Smart System2025-01-20 Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. N
07333387052854 - Navina Mini Refill Set2024-11-05 Navina Mini Refill Set. 30 Rectal Cones. Non Sterile Device.
07333387052823 - Navina™ Mini Set2024-11-05 Navina Mini Set. 1 Water Container, 30 Rectal Cones. Non Sterile Device.
07333387052847 - Navina Mini Extension Set2024-11-05Navina Mini Extension Set. 1 Water Container, 30 Rectal Cones. 1 extension tube. Non Sterile Device.
07333387052847 - Navina Mini Extension Set2024-11-05 Navina Mini Extension Set. 1 Water Container, 30 Rectal Cones. 1 extension tube. Non Sterile Device.
07333387052885 - Navina™ Mini Start Set2024-11-05 Navina Mini Start Set. 1 Water Container, 5 Rectal Cones. 1 Extension Tube. Non Sterile Device.

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