FDA.reportPublic FDA data

RUSCH

Primary DI
04026704304424
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052152
Catalog number
361226
Device description
Malecot 4 Wing 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
24026704304428PackageGS11In Commercial Distribution
44026704304422PackageGS124In Commercial Distribution
04026704304424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670430442824026704304428
4402670430442244026704304422
04026704304424040267043044244026704304424

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
10801902222951ARROWCV-22703-ECV-22703-E2026-08-19
10801902222968ARROWCV-25703-ECV-25703-E2026-08-19
10801902222975ARROWCV-26702-ECV-26702-E2026-08-19
10801902222876ARROWCV-12122-FCV-12122-F2026-08-18
10801902222906ARROWCV-15122-UFCV-15122-UF2026-08-18
10801902225631ARROWIBAS-45563-CURVIBAS-45563-CURV2026-08-18
10841156108267TRAPLINERIPN91889355672026-08-18
14026704937452WECKEFXCT1EFXCT12026-08-18
14026704937469WECKEFXSP1EFXSP12026-08-18
14026704937476WECKEFX002EFX0022026-08-18
10801902124354ARROWIPN001121AA-006052016-09-16
10801902145496ARROWIPN039727SAC-01618-1A2019-07-29
10801902160734ARROWIPN915294AI-071212019-12-19
10801902161335ARROWIPN915831AI-071342020-01-27
10801902168846ARROWIPN916860CS-24701-E2022-11-29
10801902171402ARROWIPN917137CA-45703-P1A2022-02-16
10801902172508ARROWIPN917417CS-24306-E2022-11-29
10801902180268ARROWIPN917220AI-071212021-08-19
10801902180589ARROWIPN918510CS-12702-E2022-11-29
10801902180756ARROWIPN917232AI-071342021-08-11

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
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
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