FDA.report

RUSCH

Primary DI
44026704303012
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN050595
Catalog number
183405240
Device description
RUSCH Gold 3 Way Foley Catheter
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
true

Related Records

Contact Domains

Product Codes

CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704303018PackageGS110In Commercial Distribution
44026704303012PackageGS110In Commercial Distribution
14026704303011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2402670430301824026704303018
4402670430301244026704303012
1402670430301114026704303011

GMDN Terms

TermDefinition
Single-administration urethral drainage/irrigation catheterA sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device.

Sterilization Methods

Method

Contacts

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
false

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