FDA.report

RUSCH

Primary DI
04026704710904
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN915205
Catalog number
173810-000220
Published
2020-02-06
Public version status
New
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
EZLCATHETER, RETENTION TYPE, BALLOON

Product Code Classifications

CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704710904PackageGS15In Commercial Distribution
24026704710908PackageGS172In Commercial Distribution
14026704710901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704710904040267047109044026704710904
2402670471090824026704710908
1402670471090114026704710901

GMDN Terms

TermDefinition
Indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter0.288Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
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
false
No natural rubber latex
true
Sterilization required before use
false

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20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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10884522000024Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000031Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000048Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000055Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000062Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
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27290110066486Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066493Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066509Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066523Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
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