FDA.reportPublic FDA data

RUSCH

Primary DI
24026704662016
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN039320
Catalog number
RLA-162-3R
Device description
16FR Red Rubber
Published
2019-06-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010420000RUSCH MMG/O'NEIL CATHETERRusch, Inc.2001-05-09FCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704662016PackageGS1100In Commercial Distribution
04026704551002PreviousGS10
14026704662019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670466201624026704662016
04026704551002040267045510024026704551002
1402670466201914026704662019

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Height0.5Inch
Length11Inch
Width6.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00false
Special Storage Condition, Specify00None

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253029079DoverCardinal Health 200, LLCKOD2025-04-07
10192253029086DoverCardinal Health 200, LLCKOD2025-04-07
10192253029093DoverCardinal Health 200, LLCKOD2025-04-07
10192253029109DoverCardinal Health 200, LLCKOD2025-04-07
10192253029116DoverCardinal Health 200, LLCKOD2025-04-07
10192253029123DoverCardinal Health 200, LLCKOD2025-04-07
10192253030310DoverCardinal Health 200, LLCKOD2025-04-07
10192253030327DoverCardinal Health 200, LLCKOD2025-04-07
10192253030334DoverCardinal Health 200, LLCKOD2025-04-07
10192253030341DoverCardinal Health 200, LLCKOD2025-04-07
10192253030358DoverCardinal Health 200, LLCKOD2025-04-07
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253030648DoverCardinal Health 200, LLCKOD2025-01-15
10192253031041DoverCardinal Health 200, LLCKOD2025-01-15
10192253031423DoverCardinal Health 200, LLCKOD2025-01-15
10192253030624DoverCardinal Health 200, LLCKOD2025-01-14
10192253031409DoverCardinal Health 200, LLCKOD2025-01-14
10192253031416DoverCardinal Health 200, LLCKOD2025-01-14
10192253038897DoverCardinal Health 200, LLCKOD2025-01-14
10192253066203DoverCardinal Health 200, LLCKOD2024-09-04
10192253066210DoverCardinal Health 200, LLCKOD2024-09-04
10192253066227DoverCardinal Health 200, LLCKOD2024-09-04
10192253066234DoverCardinal Health 200, LLCKOD2024-09-04
10192253066241DoverCardinal Health 200, LLCKOD2024-09-04
10192253066258DoverCardinal Health 200, LLCKOD2024-09-04
10192253066265DoverCardinal Health 200, LLCKOD2024-09-04