FDA.reportPublic FDA data

Bard Poly Midline

Primary DI
00801741107467
Brand
Bard Poly Midline
Company
Bard Access Systems, Inc.
Model
CK000552
Catalog number
CK000552
Device description
Catheter Placement 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
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
10801741107464PackageGS13In Commercial Distribution
00801741107467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174110746410801741107464
00801741107467008017411074678017411074670801741107467

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Length20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
044611812
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240041PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9200AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9210AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3R0001C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3R0031C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S900C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S910C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9150C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9160C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S920C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9220C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S930C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S940C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S950C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S960C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S970C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H965458160BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H965458560BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H96560M13031150BioFloNAVILYST MEDICAL, INC.LJS2021-06-24
H96560M13031130BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
H96560M13031160BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
H96560M0411550BioFloNAVILYST MEDICAL, INC.LJS2021-05-14
H96560M0411560BioFloNAVILYST MEDICAL, INC.LJS2021-05-14
H96560M13031110BioFloNAVILYST MEDICAL, INC.LJS2021-03-19
H954PKM033511S0BioFloNAVILYST MEDICAL, INC.LJS2021-03-08