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
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16

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
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