FDA.reportPublic FDA data

RUSCH

Primary DI
04026704304417
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052150
Catalog number
361224
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
24026704304411PackageGS11In Commercial Distribution
44026704304415PackageGS124In Commercial Distribution
04026704304417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670430441124026704304411
4402670430441544026704304415
04026704304417040267043044174026704304417

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
00801902002266ARROWIPN000082AI-071342016-09-16
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31

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
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
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