FDA.reportPublic FDA data

Catheter Repair Kit

Primary DI
10801741045087
Brand
Catheter Repair Kit
Company
Bard Access Systems, Inc.
Model
5587000
Catalog number
5587000
Device description
Catheter Repair Kit with Replacement Connector
Published
2017-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFKKit, repair, catheter, hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFKKit, Repair, Catheter, HemodialysisGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741045087PackageGS15In Commercial Distribution
00801741045080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104508710801741045087
00801741045080008017410450808017410450800801741045080

GMDN Terms#

Term, Definition table
TermDefinition
Catheter care kitA collection of sterile devices designed to clean or otherwise maintain catheter patency. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741240034PowerPICC SOLOCK001093CK0010932026-05-27
00801741240041PowerPICC Provena SOLOCK001094CK0010942026-05-27
00801741240058PowerPICC Provena SOLOCK001095CK0010952026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001096CK0010962026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGCK001097CK0010972026-05-27
10801741082983StatLockS04020010S040200102025-05-02
10801741087582StatLockD05000002AD05000002A2025-05-02
10801741188852StatLockSEC2404320SEC24043202020-04-22
10801741188869StatLockSEC2404321SEC24043212020-04-22
00801741075452SecurisSEC0100SEC01002019-10-17
00801741081248StatLock068400047206840004722025-05-02
00801741081255StatLock068400049306840004932025-05-02
00801741081521STATLOCKCV0223CV02232023-11-09
00801741081552STATLOCKCV0226CV02262023-11-09
00801741081576STATLOCKCV0321CV03212023-11-09
00801741081675STATLOCKIB0200IB02002023-11-09
00801741081682STATLOCKIV0220IV02202023-11-09
00801741081750STATLOCKIV0500IV05002023-11-09
00801741081767STATLOCKIV0501IV05012023-11-09
00801741081897STATLOCKIV0528IV05282023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20801902197379ARROWTELEFLEX INCORPORATEDNFK2022-12-08
10801902197372ARROWTELEFLEX INCORPORATEDNFK2022-12-08
20801902197355ARROWTELEFLEX INCORPORATEDNFK2022-12-02
30801902197352ARROWTELEFLEX INCORPORATEDNFK2022-12-02
20801902197409ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902197461ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902197485ARROWTELEFLEX INCORPORATEDNFK2022-12-01
10801902197402ARROWTELEFLEX INCORPORATEDNFK2022-12-01
30801902197468ARROWTELEFLEX INCORPORATEDNFK2022-12-01
10801902197488ARROWTELEFLEX INCORPORATEDNFK2022-12-01
20801902195337ARROWTELEFLEX INCORPORATEDNFK2022-11-15
20801902196723ARROWTELEFLEX INCORPORATEDNFK2022-11-15
30801902195334ARROWTELEFLEX INCORPORATEDNFK2022-11-15
30801902196720ARROWTELEFLEX INCORPORATEDNFK2022-11-15
20801902195238ARROWTELEFLEX INCORPORATEDNFK2022-11-11
30801902195235ARROWTELEFLEX INCORPORATEDNFK2022-11-11
20801902197423ARROWTELEFLEX INCORPORATEDNFK2022-11-09
10801902197426ARROWTELEFLEX INCORPORATEDNFK2022-11-09
00884908158205CATHETER REPAIR KITMedical Components, Inc.NFK2020-11-26
30884908158206CATHETER REPAIR KITMedical Components, Inc.NFK2020-11-26
00884908146042N/AMedical Components, Inc.NFK2019-09-05
30884908146043N/AMedical Components, Inc.NFK2019-09-05
00801741045080Catheter Repair KitBard Access Systems, Inc.NFK2017-05-29
00801741045103Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
00801741045110RetrO Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
20801741045107Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
20801741045114RetrO Catheter Repair KitBard Access Systems, Inc.NFK2015-12-04
00884908039658CATHETER REPAIR KITMedical Components, Inc.NFK2015-10-24
00884908039856REPAIR KITMedical Components, Inc.NFK2015-10-23
00884908001891Catheter Repair KitMedical Components, Inc.NFK2015-10-23