FDA.reportPublic FDA data

RUSCH

Primary DI
04026704072514
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052232
Catalog number
395763-000140
Device description
Rectal 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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAPCYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAPCystometric Gas (Carbon-Dioxide) On Hydraulic DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962472000RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.1996-08-27FAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704072518PackageGS110In Commercial Distribution
54026704072519PackageGS112In Commercial Distribution
04026704072514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670407251824026704072518
5402670407251954026704072519
04026704072514040267040725144026704072514

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic catheterA long, thin, sterile, flexible or semi-rigid tube designed for connection to urodynamic measuring equipment for urodynamic examination of a patient. It is inserted into the bladder via the urethra or non-surgically via a stoma for cystometry, to drain the bladder to facilitate measurement of urinary output, and for urethral pressure and other urethral and voiding pressure examinations. It is available with various lumens (e.g., single, double, triple) providing one or more openings at the distal end, and is calibrated in increments to assist in positioning. It may be dedicated to a gas or water infusion technique. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.7Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

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
18054655025986Urethral Catheter ElectrodeSPES MEDICA SPAFAP2025-02-24
18054655026006Urethral Catheter ElectrodeSPES MEDICA SPAFAP2025-02-24
18054655030386Urethral Catheter ElectrodeSPES MEDICA SPAFAP2025-02-24
18054655025979Urethral Catheter ElectrodeSPES MEDICA SPAFAP2021-05-24
18054655026013Urethral Catheter ElectrodeSPES MEDICA SPAFAP2021-05-24
18054655012894Spes Medica Pudendal ElectrodeSPES MEDICA SPAFAP2020-03-11
08054655012897Spes Medica Pudendal ElectrodeSPES MEDICA SRLFAP2020-03-11
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00827002155404CookCOOK INCORPORATEDFAP2016-09-24