FDA.reportPublic FDA data

Peristeen

Primary DI
05708932514958
Brand
Peristeen
Company
Coloplast A/S
Model
29128
Catalog number
29128
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932514958PackageGS110In Commercial Distribution
05708932514965PackageGS110In Commercial Distribution
05708932648899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932514958057089325149585708932514958
05708932514965057089325149655708932514965
05708932648899057089326488995708932648899

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30
05701780437066SenSura Mio Convex1373201373202026-04-30
05701780437127SenSura Mio Convex1373301373302026-04-30
05701780437561SenSura Mio Convex1680101680102026-04-30
05701780438384SenSura Mio Convex1680501680502026-04-30
05701780439923SenSura Mio Convex1682101682102026-04-30
05701780440462SenSura Mio Convex1682201682202026-04-30
05701780440875SenSura Mio Convex1682301682302026-04-30
05701780441292SenSura Mio Convex1682501682502026-04-30
05701780441926SenSura Mio Convex1682601682602026-04-30
05701780442572SenSura Mio Convex1682701682702026-04-30
05701780443074SenSura Mio Convex1683001683002026-04-30
05701780443371SenSura Mio Convex1683101683102026-04-30
05701780444026SenSura Mio Convex1683201683202026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253068762CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
50192253068779CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
50192253068809CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
00842071146412MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00842071146429MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00816340023162Transfer StrawNEODEVICES INCKNT2026-02-05
20885632464475HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-30
20197344200358MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200365MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200372MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200389MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20885632465069HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465076HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465083HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465106HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465113HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465120HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465137HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465144HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465175HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465281HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465335HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465342HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465380HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465434HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465465HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465489HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632464642HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22
20885632464659HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22
20885632464802HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22