AccessGUDID - DEVICE: Navina™ Catheter set Small (07392532243837)

GUDID

Device Identifier (DI) Information

Brand Name: Navina™ Catheter set Small
Version or Model: 68943
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6894340
Company Name: Wellspect AB

Primary DI Number: 07392532243837
Issuing Agency: GS1
Commercial Distribution End Date: October 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 351118942 *Terms of Use

Device Description: Navina Transanal Irrigation. Rectal Catheter set small. 10 Rectal catheters small. Single use. Non sterile Device. Rx Only.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46202	Rectal irrigation system catheter	A flexible tube that is a component of a rectal irrigation system and designed to be inserted into the rectum (may be held in position by an inflatable retention balloon) where it serves as a conduit for water introduced into the rectum. 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. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, gastrointestinal (and accessories)
FCE	Enema kit

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 2b7d436e-91ad-49d7-84f6-35c34904b330
Public Version Date: October 09, 2023
Public Version Number: 6
DI Record Publish Date: December 17, 2019