FDA.report

Peristeen

Primary DI
05708932487009
Brand
Peristeen
Company
Coloplast A/S
Model
29123
Catalog number
29123
Device description
Peristeen Anal irrigation. Accessory unit. Non sterile. Rx only.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708932487009PackageGS110In Commercial Distribution
05708932487016PackageGS110In Commercial Distribution
05708932648882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708932487009057089324870095708932487009
05708932487016057089324870165708932487016
05708932648882057089326488825708932648882

GMDN Terms

TermDefinition
Rectal irrigation system catheterA 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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