FDA.reportPublic FDA data

RUSCH

Primary DI
24026704066128
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN044966
Catalog number
546231-000000
Device description
Adhesive patch, big
Published
2015-10-16
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
KOBCATHETER, SUPRAPUBIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOBCatheter, Suprapubic (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952187000RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILERusch, Inc.1995-07-25KOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44026704066122PackageGS110In Commercial Distribution
24026704066128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4402670406612244026704066122
2402670406612824026704066128

GMDN Terms#

Term, Definition table
TermDefinition
Universal patient tubing holder, non-sterileA small, non-sterile device with a locking/holding mechanism designed to secure tubing or tubing-like devices (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. It is not designed to hold a specific type or brand of tubing. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight; Keep dry

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842071150976AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
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00842071152765MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152772MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152789MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152796MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152802MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152819MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152826MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152833MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152840MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152857MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152864MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152871MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152888MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152895MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152901MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152918MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152925MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071149932MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149949MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149956MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149963MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149970MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149987MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149994MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071150006MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16