FDA.reportPublic FDA data

External Catheter Segment for Hickman Triple-Lumen CV Catheters

Primary DI
10801741036511
Brand
External Catheter Segment for Hickman Triple-Lumen CV Catheters
Company
Bard Access Systems, Inc.
Model
0601790
Catalog number
0601790
Device description
External Catheter Segment for Hickman 10F Triple Lumen CV Catheters Repair Kit
Published
2015-09-24
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
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741036511PackageGS180In Commercial Distribution
00801741036514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103651110801741036511
00801741036514008017410365148017410365140801741036514

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French

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
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
00801741082078STATLOCKIV0568IV05682023-11-09
00801741082085STATLOCKIV0569IV05692023-11-09
00801741082092STATLOCKIV0570IV05702023-11-09
00801741082139STATLOCKIV0577IV05772023-11-09
00801741082153STATLOCKIV0579IV05792023-11-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H787MRC3S910C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H787MRC3S940C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H787MRC3S960C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H956PKM61014921S0BioFloNAVILYST MEDICAL, INC.LJS2020-11-04
H787MRC3S01US0C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2020-07-09
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H96560M0224770BioFloNAVILYST MEDICAL, INC.LJS2020-06-26
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