FDA.reportPublic FDA data

RUSCH

Primary DI
24026704058383
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN006957
Catalog number
436700-000200
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

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
04026704058389Direct MarkingGS10
44026704058387PackageGS172In Commercial Distribution
24026704058383PrimaryGS10
34026704058380Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704058389040267040583894026704058389
4402670405838744026704058387
2402670405838324026704058383
3402670405838034026704058380

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 Gauge20French

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
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902213188ARROWIPN927188DLX-200-CURV2026-07-23
10841156108908TRAPLINERIPN91750955672026-07-23
10841156111311LANGSTONIPN93013555402026-07-23
14026704944450RUSCH2205000602205000602026-07-23
14026704945402RUSCH2204001402204001402026-07-23
14026704945419RUSCH2204001602204001602026-07-23
14026704945426RUSCH2205000802205000802026-07-23
14026704945617RUSCH2204000802204000802026-07-23
14026704945624RUSCH2204001002204001002026-07-23
14026704945846RUSCH2214000602214000602026-07-23
20801902193548ARROWIPN920133CS-15362-SPM2026-07-23
20801902193593ARROWIPN920138CS-15192-VF2026-07-23
14026704927453GIBECKIPN929805133122025-07-31
10801902226485ARROWIPNB00690ASK-21242-CWH12026-07-22
14026704624697RUSCHIPN04946312241102026-07-22
14026704911810PLEUR-EVACIPN927045S-1150-08LF2026-07-22
30801902193538ARROWIPN920132CS-15322-SPM2026-07-22
10841495149471QUIKCLOT1881882026-07-17
14026704645333WECKIPN9142504200232026-07-21
14026704714510LMA ATOMIZATIONIPN916119MAD300B2026-07-21

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
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
04026704058419RUSCHTELEFLEX 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