FDA.reportPublic FDA data

RUSCH

Primary DI
24026704549843
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN053441
Catalog number
A1500M
Published
2018-09-15
Public version status
Update
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
24026704549843PrimaryGS10
14026704549846Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670454984324026704549843
1402670454984614026704549846

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage catheterA sterile, 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, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
144
Premarket exempt
true
Lot or batch
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
14026704923714RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
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