FDA.reportPublic FDA data

RUSCH

Primary DI
44026704304552
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052178
Catalog number
361720
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
OTC
false
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
24026704304558PackageGS11In Commercial Distribution
44026704304552PackageGS124In Commercial Distribution
04026704304554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670430455824026704304558
4402670430455244026704304552
04026704304554040267043045544026704304554

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.

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
true
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
44026704304347RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304354RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304361RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304374RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304381RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304398RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304408RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304411RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304422RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304435RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304446RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304453RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304460RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304473RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304484RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304491RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304507RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304514RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304521RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304534RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304541RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304569RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304576RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304583RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304590RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304606RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304613RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
44026704304620RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
24026704304633RUSCHTELEFLEX INCORPORATEDFEW2016-09-16
10801741076852Bardex® Angle Drain Four-Wing Malecot TypeC. R. Bard, Inc.FEW2016-07-28