FDA.reportPublic FDA data

RUSCH

Primary DI
04026704304547
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052176
Catalog number
361718
Device description
Pezzar 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
FEWCatheter, malecot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEWCatheter, MalecotGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704304541PackageGS11In Commercial Distribution
44026704304545PackageGS124In Commercial Distribution
04026704304547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670430454124026704304541
4402670430454544026704304545
04026704304547040267043045474026704304547

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic drainage catheterA flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
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
04026704304349RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304356RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304363RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304370RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304387RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304394RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304400RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304417RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304424RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304431RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304448RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304455RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304462RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304479RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304486RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304493RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304509RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304516RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304523RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304530RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304554RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304561RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304578RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304585RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304592RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304608RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304615RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304622RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304639RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304347RUSCHTELEFLEX INCORPORATEDFEW2016-09-16