FDA.reportPublic FDA data

RUSCH

Primary DI
14026704923714
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN928743
Catalog number
A1000
Device description
Contents: RUSCH Golden-Drain® Catheter Large Size Catheter Single Sided Adhesive
Published
2024-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNYSHEATH, CORRUGATED RUBBER, FOR NON-INDWELLING CATHETER, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704923711PackageGS1144In Commercial Distribution
04026704549504PreviousGS10
14026704923714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670492371124026704923711
04026704549504040267045495044026704549504
1402670492371414026704923714

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage balloon catheter, non-antimicrobialA flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704923721RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
14026704923738RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
24026704923711RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
24026704923728RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
24026704923735RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
00860005762620AcanthusAcanthus Medical Creations LLCNNY2021-03-15
00860005762613AcanthusAcanthus Medical Creations LLCNNY2021-03-15
00860005762606AcanthusAcanthus Medical Creations LLCNNY2021-02-15
14026704661708RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
14026704661715RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
14026704661722RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
14026704661753RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
24026704661705RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
24026704661712RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
24026704661729RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
24026704661750RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
14026704660404RUSCHTELEFLEX INCORPORATEDNNY2019-01-29
14026704660411RUSCHTELEFLEX INCORPORATEDNNY2019-01-29
04026704549504RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
04026704549542RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
04026704549566RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
04026704549863RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549508RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549546RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549560RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549867RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549836RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549843RUSCHTELEFLEX INCORPORATEDNNY2018-09-15