RUSCH

Primary DI: 34026704663522
Brand: RUSCH
Company: TELEFLEX INCORPORATED
Model: IPN039009
Catalog number: 345112
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

teleflex.com

Product Codes

Code	Name
FBW	FILIFORM AND FILIFORM FOLLOWER

Product Code Classifications

Code	Device	Specialty	Class
FBW	Filiform And Filiform Follower	Gastroenterology, Urology	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
24026704663525	Package	GS1	10	In Commercial Distribution
34026704663522	Package	GS1	6	In Commercial Distribution
04026704542963	Previous	GS1	0
14026704663528	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
24026704663525	24026704663525
34026704663522	34026704663522
04026704542963	04026704542963	4026704542963
14026704663528	14026704663528

GMDN Terms

Term	Definition
Indwelling urethral drainage catheter	A 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.

Term

Definition

Indwelling urethral drainage catheter

A 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

Type	Value	Unit
Height	0.31	Inch
Length	19.5	Inch
Width	3	Inch

Storage And Handling

Type	Low	High	Condition
Special Storage Condition, Specify	0	0	false

Sterilization Methods

Method

Contacts

Phone	Email
+1(919)544-8000	CS@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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