FDA.report

Peristeen Plus

Primary DI
05701780237772
Brand
Peristeen Plus
Company
Coloplast A/S
Model
29149
Catalog number
29149
Device description
Peristeen Plus Transanal irrigation / Peristeen Plus . Balloon catheter. 15 balloon catheters Small 1 water bag.
Published
2021-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
05701780237772PackageGS11In Commercial Distribution
05701780237789PackageGS110In Commercial Distribution
05701780237765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05701780237772057017802377725701780237772
05701780237789057017802377895701780237789
05701780237765057017802377655701780237765

GMDN Terms

TermDefinition
Rectal irrigation kitA collection of non-sterile devices intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation; it is not intended for colostomy site irrigation or irrigation of the entire colon. It includes a rectal catheter and additional non-powered rectal irrigation devices (e.g., fluid container) which may include a single-use device(s). It is intended for use in the home and healthcare facility. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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
true
Sterilization required before use
false

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