FDA.reportPublic FDA data

RUSCH

Primary DI
04026704304431
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN052154
Catalog number
361228
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
24026704304435PackageGS11In Commercial Distribution
44026704304439PackageGS124In Commercial Distribution
04026704304431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670430443524026704304435
4402670430443944026704304439
04026704304431040267043044314026704304431

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
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

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
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