FDA.report

RUSCH

Primary DI
34026704663423
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN038999
Catalog number
342103
Device description
Disposable
Published
2019-06-07
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
FBWFILIFORM AND FILIFORM FOLLOWER

Product Code Classifications

CodeDeviceSpecialtyClass
FBWFiliform And Filiform FollowerGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704663426PackageGS110In Commercial Distribution
34026704663423PackageGS16In Commercial Distribution
04026704542864PreviousGS10
14026704663429PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
2402670466342614240267046634262Indicator 2 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
3402670466342314340267046634233Indicator 3 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
04026704542864140402670454286404026704542864Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.
1402670466342914140267046634291Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.

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
Height0.01Inch
Length19Inch
Width2.9Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00false
Special Storage Condition, Specify00None

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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