FDA.reportPublic FDA data

Peristeen

Primary DI
05708932514941
Brand
Peristeen
Company
Coloplast A/S
Model
29127
Catalog number
29127
Device description
Peristeen Anal irrigation. Accessory unit. 15 rectal catheters small 1 bag. 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
05708932514941PackageGS110In Commercial Distribution
05708932514934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932514941057089325149415708932514941
05708932514934057089325149345708932514934

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
true
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
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

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