AccessGUDID - DEVICE: Peristeen (05708932480253)

GUDID

Device Identifier (DI) Information

Brand Name: Peristeen
Version or Model: 29122
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 29122
Company Name: Coloplast A/S

Primary DI Number: 05708932480253
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Peristeen Transanal irrigation. Accessory unit. 15 rectal catheters Regular, 1 water bag. Non sterile. 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":	Yes
For Single-Use:	No
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
46204	Rectal irrigation system fluid container	A receptacle that is a component of a rectal irrigation system and designed to hold the water used for irrigation. It is typically a closed container (e.g., a plastic bag) with connecting ports for the system control unit; it does not include a rectal nozzle/catheter or control unit. 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 reusable device.	Active	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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7e4c0ff-f832-49f8-aca4-c6fced1898c1
Public Version Date: June 19, 2024
Public Version Number: 4
DI Record Publish Date: September 20, 2016