AccessGUDID - DEVICE: Peristeen (05708932489904)

GUDID

Device Identifier (DI) Information

Brand Name: Peristeen
Version or Model: 29124
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 29124
Company Name: Coloplast A/S

Primary DI Number: 05708932489904
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. Straps. 10 sets of 2 straps. 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:	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?
45510	Manual rectal irrigation system	A portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. It typically consists of a control unit that regulates the air/water balance and includes a manually-operated hand pump to propel the water, a container for the water (e.g., a plastic bag), and a rectal catheter to channel the water. It is intended for use in the home and healthcare facility. 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: 2d11158f-1eba-4add-8107-f000c9b3256a
Public Version Date: March 19, 2024
Public Version Number: 3
DI Record Publish Date: September 20, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05708932487023	10	05708932489904	2024-03-15	Not in Commercial Distribution	Retail box
05708932487030	10	05708932487023	2024-03-15	Not in Commercial Distribution	Shipper box