FDA.reportPublic FDA data

RUSCH

Primary DI
04026704058440
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN006963
Catalog number
436700-000320
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
04026704058440Direct MarkingGS10
44026704058448PackageGS172In Commercial Distribution
24026704058444PrimaryGS10
34026704058441Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704058440040267040584404026704058440
4402670405844844026704058448
2402670405844424026704058444
3402670405844134026704058441

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 Gauge32French

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
00801902002266ARROWIPN000082AI-071342016-09-16
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31

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
04026704058419RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058426RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058433RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058457RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
04026704058464RUSCHTELEFLEX INCORPORATEDGBT2016-09-30
24026704058352RUSCHTELEFLEX INCORPORATEDGBT2016-09-29
44026704058356RUSCHTELEFLEX INCORPORATEDGBT2016-09-29