FDA.reportPublic FDA data

RUSCH

Primary DI
04026704058419
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN006960
Catalog number
436700-000260
Device description
Rectal tube, 50 cm, open tip, 1 eye
Published
2016-09-30
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBTCATHETER, RECTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBTCatheter, RectalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704058419Direct MarkingGS10
44026704058417PackageGS172In Commercial Distribution
24026704058413PrimaryGS10
34026704058410Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704058419040267040584194026704058419
4402670405841744026704058417
2402670405841324026704058413
3402670405841034026704058410

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
Catheter Gauge26French

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902227239ARROWIPNB00706ASK-04001-NYP22026-08-27
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
14026704936011QUIKCLOT404040402026-08-27
14026704657169HUDSON RCIIPN91399432302019-05-09
14026704657176HUDSON RCIIPN91399532602019-05-09
04026704303090RUSCHIPN0512673181142016-09-16
04026704387793HUDSON RCIIPN04421532302016-09-16
04026704596430HUDSON RCIIPN04421632602016-09-16
05060112313851LMA AIRWAY MANAGEMENTIPN0478971920302018-09-15
10801902216486ARROWIPN928616EC-050002023-10-26
10801902216516ARROWIPN928618LR-055022023-10-26
10801902216523ARROWIPN928619LR-055032023-10-26
10841156111250GUIDELINERIPN93018852702025-07-14
14026704303448RUSCHIPN0505311807301402016-09-16
14026704303486RUSCHIPN0505351807301802016-09-16
14026704632869DEKNATELIPN0287367-9222019-09-04
14026704670472DEKNATELIPN914541X-4769W2020-05-27
14026704926944RUSCHIPN9297471807052602026-08-25
14026704926951RUSCHIPN9297481807052802026-08-25
14026704926968RUSCHIPN9297491807053002026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704058345RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058369RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058376RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058383RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058390RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058406RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058413RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058420RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058437RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058444RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058451RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058468RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
44026704058349RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
44026704058363RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
44026704058370RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
44026704058387RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
44026704058394RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
44026704058400RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058426RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058433RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058440RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058457RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058464RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058352RUSCHTELEFLEX INCORPORATEDGBT2016-09-29
44026704058356RUSCHTELEFLEX INCORPORATEDGBT2016-09-29