AccessGUDID - DEVICE: Navina™ Smart App for iOS (07333387030388)

GUDID

Device Identifier (DI) Information

Brand Name: Navina™ Smart App for iOS
Version or Model: 75750
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 75750
Company Name: Wellspect AB

Primary DI Number: 07333387030388
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 351118942 *Terms of Use
Previous DI: 07392532242373

Device Description: Navina Smart Transanal Irrigation. Bowel diary APP

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61114	Rectal irrigation system application software	An application software program intended to store and display data relating to rectal irrigation procedures (e.g., volumes of water used) to assist a review/evaluation of the procedure; it is not intended to store patient clinical data, control the system, or make recommendations to the user. It is typically for installation in an off-the-shelf desktop, laptop, tablet computer or smartphone, which will require a connection to the rectal irrigation system control unit to automatically receive data. It is intended to be used in the home and healthcare facility. It typically includes upgrades to the software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical device data system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry place at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: edc0198f-f307-446f-9ffe-59e6904c09d6
Public Version Date: October 06, 2023
Public Version Number: 2
DI Record Publish Date: September 25, 2023