FDA.report

Peristeen Plus

Primary DI
05701780236232
Brand
Peristeen Plus
Company
Coloplast A/S
Model
29143
Catalog number
29143
Device description
Peristeen Plus Transanal irrigation / Peristeen Plus . Balloon catheter.
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
05701780236232PackageGS110In Commercial Distribution
05701780236249PackageGS110In Commercial Distribution
05701780236225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05701780236232057017802362325701780236232
05701780236249057017802362495701780236249
05701780236225057017802362255701780236225

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.

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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