FDA.reportPublic FDA data

TELEFLEX

Primary DI
04026704331109
Brand
TELEFLEX
Company
TELEFLEX INCORPORATED
Model
IPN050840
Catalog number
21096080
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
44026704331107PackageGS1100In Commercial Distribution
04026704331109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4402670433110744026704331107
04026704331109040267043311094026704331109

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 Diameter2.7Millimeter

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
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
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