FDA.reportPublic FDA data

RUSCH

Primary DI
04026704323630
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN053015
Catalog number
76000
Device description
Catheter Insertion Kit
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
FINTank, holding, dialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FINTank, Holding, DialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010420000RUSCH MMG/O'NEIL CATHETERRusch, Inc.2001-05-09FCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704323634PackageGS1100In Commercial Distribution
04026704323630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670432363424026704323634
04026704323630040267043236304026704323630

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.

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
BC0021BICARB, DUAL, 100, MIX/DEL, EDUCTORBETTER WATER, LLCFIN2024-11-13
BC0121BICARB, DUAL, 60, MIX/DEL, EDUCTORBETTER WATER, LLCFIN2024-11-13
00852456007085Sodium Bicarbonate Mixing and Distribution SystemIsopure, Corp.FIN2017-09-20
B285SDSCB2001BiPro Bicarb Mixing/Distribution SystemMEDICAL SOLUTIONS INTERNATIONAL, INC.FIN2017-06-30
00817927020284AmeriWater 00BCM55AMERIWATER, LLCFIN2017-01-10
00817927020291AmeriWater 00BCM100AMERIWATER, LLCFIN2017-01-10
00817927020307AmeriWater 00BCMD55AMERIWATER, LLCFIN2017-01-10
00817927020314AmeriWater 00BCMD100AMERIWATER, LLCFIN2017-01-10
00817927020086AmeriWater 0077-0010 Ozone Disinfection SystemAMERIWATER, LLCFIN2017-01-06
00817927020055AmeriWater 00BC55-55 Bicarb Mix and Distribution SystemAMERIWATER, LLCFIN2017-01-05
00817927020062AmeriWater 00BC100-100 Bicarb Mix and Distribution SystemAMERIWATER, LLCFIN2017-01-05
00817927020079AmeriWater 00BC100-200 Bicarb Mix and Distribution SystemAMERIWATER, LLCFIN2017-01-05
00817492021785MCB SeriesMAR COR PURIFICATION, INC.FIN2016-12-29
00817492021310MCB SeriesMAR COR PURIFICATION, INC.FIN2016-10-28
BC0001BICARB, DUAL, 100, MIX/DELBETTER WATER, LLCFIN2016-10-13
BC0002BICARB, DUAL, 100, MIX/DEL/1000BETTER WATER, LLCFIN2016-10-13
BC0011BICARB, DUAL, 100, MIX/DEL, SPBETTER WATER, LLCFIN2016-10-13
BC0012BICARB, DUAL, 100, MIX/DEL/1000, SPBETTER WATER, LLCFIN2016-10-13
BC0101BICARB, DUAL 60, MIX/DELVBETTER WATER, LLCFIN2016-10-13
BC0111BICARB, DUAL, 60, MIX/DEL, SPBETTER WATER, LLCFIN2016-10-13
BC0201BICARB, SINGLE, 100, MIX/DELBETTER WATER, LLCFIN2016-10-13
BC0202BICARB, SINGLE, 100, MIX-ONLYBETTER WATER, LLCFIN2016-10-13
BC0211BICARB, SINGLE, 100, MIX/DEL, SPBETTER WATER, LLCFIN2016-10-13
BC0301BICARB, SINGLE, 60, MIX/DELBETTER WATER, LLCFIN2016-10-13
BC0302BICARB, SINGLE, 60, MIX-ONLYBETTER WATER, LLCFIN2016-10-13
00817492020979MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492020986MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492020993MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492021006MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23
00817492021013MCB SeriesMAR COR PURIFICATION, INC.FIN2016-09-23