AccessGUDID - DEVICE: Navina™ Rectal Catheter set regular (07392532168499)

GUDID

Device Identifier (DI) Information

Brand Name: Navina™ Rectal Catheter set regular
Version or Model: 68940
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6894040
Company Name: Wellspect AB

Primary DI Number: 07392532168499
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 351118942 *Terms of Use

Device Description: Navina Transanal Irrigation. Rectal Catheter set regular. 10 Rectal catheters regular. 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:	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?
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)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 442bef80-a0a2-4ab1-9b8b-9ed342d4694b
Public Version Date: April 01, 2024
Public Version Number: 7
DI Record Publish Date: November 10, 2017