FDA.reportPublic FDA data

RUSCH

Primary DI
04026704304578
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052182
Catalog number
361724
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
24026704304572PackageGS11In Commercial Distribution
44026704304576PackageGS124In Commercial Distribution
04026704304578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670430457224026704304572
4402670430457644026704304576
04026704304578040267043045784026704304578

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
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24
15060112315043LMA AIRWAY MANAGEMENTIPN0487821280502026-06-24
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20

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
04026704304547RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304554RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
04026704304561RUSCHTELEFLEX 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