FDA.reportPublic FDA data

RUSCH

Primary DI
24026704058437
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN006962
Catalog number
436700-000300
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
04026704058433Direct MarkingGS10
44026704058431PackageGS172In Commercial Distribution
24026704058437PrimaryGS10
34026704058434Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704058433040267040584334026704058433
4402670405843144026704058431
2402670405843724026704058437
3402670405843434026704058434

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 Gauge30French

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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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
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