FDA.reportPublic FDA data

RUSCH

Primary DI
44026704052941
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052270
Catalog number
402140-000080
Device description
Bladder catheter, cyl. tip, 1 eye
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14026704052940Direct MarkingGS10
24026704052947PackageGS110In Commercial Distribution
44026704052941PackageGS142In Commercial Distribution
04026704052943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1402670405294014026704052940
2402670405294724026704052947
4402670405294144026704052941
04026704052943040267040529434026704052943

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, reusableA flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]. The device may be male or female dedicated. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

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
1
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
true
Expiration date on label
true
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704942057RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942060RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942077RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942088RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942095RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942101RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942114RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942125RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942138RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942149RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942152RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942163RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942170RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942183RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
20192253024255DoverCardinal Health 200, LLCKOD2026-03-20
50192253024263DoverCardinal Health 200, LLCKOD2026-03-20
50192253024270DoverCardinal Health 200, LLCKOD2026-03-20
50192253024300DoverCardinal Health 200, LLCKOD2026-03-20
20885380202596DoverCardinal Health 200, LLCKOD2026-03-20
50850058254673EZ-Advancer®HR PHARMACEUTICALS INC.KOD2026-03-06
04026704937158RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937166RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
04026704937172RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937180RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
04026704937196RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937203RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
20854913006185Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-17
20854913006192Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-17
20854913006154Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-16
20854913006161Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-16