FDA.reportPublic FDA data

TELEFLEX

Primary DI
04026704331130
Brand
TELEFLEX
Company
TELEFLEX INCORPORATED
Model
IPN050843
Catalog number
21096140
Device description
RUSCH MMG H2O: Hydrophilic closed-system intermittent 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
GBMCATHETER, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020714000RUSCH FLONEIL; FLOCATH INTROGELRusch Intl.2002-07-01GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44026704331138PackageGS1100In Commercial Distribution
04026704331130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4402670433113844026704331138
04026704331130040267043311304026704331130

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.7Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
14026704922649RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922656RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922663RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922670RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922687RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922694RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922700RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922717RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922724RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922731RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704922748RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945433RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945440RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945457RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945464RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945471RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945488RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945495RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945501RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945518RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945815RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945822RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945839RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945853RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945860RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945877RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945884RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945891RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945907RUSCHTELEFLEX INCORPORATEDGBM2026-07-28
14026704945914RUSCHTELEFLEX INCORPORATEDGBM2026-07-28