FDA.reportPublic FDA data

BARD Poly Midline

Primary DI
00801741095924
Brand
BARD Poly Midline
Company
Bard Access Systems, Inc.
Model
CK000198A
Catalog number
CK000198A
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
10801741095921PackageGS15In Commercial Distribution
00801741095924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174109592110801741095921
00801741095924008017410959248017410959240801741095924

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

Contacts#

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

Regulatory Flags#

DUNS number
044611812
Device count
1
Kit
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
00801741241055PowerPICC® Provena™ CatheterCK000909BCK000909B2026-10-29
00801741241062PowerPICC® Provena™ CatheterCK001006BCK001006B2026-10-29
00801741038204MicroEZ Introducer012894501289452016-02-08
00801741038211MicroEZ Introducer012895001289502016-02-08
00801741038228MicroEZ Introducer012896001289602016-02-08
00801741038235MicroEZ Introducer022894502289452016-02-08
00801741038242MicroEZ Introducer022895002289502016-02-08
00801741038259MicroEZ Introducer022896002289602016-02-08
00801741038266Peel-Apart Percutaneous Introducer Kit060111006011102016-02-22
00801741038273Peel-Apart Percutaneous Introducer Kit060111306011132016-02-22
00801741038280Peel-Apart Percutaneous Introducer Kit060111406011142016-02-22
00801741038297Peel-Apart Percutaneous Introducer Kit060111506011152016-02-22
00801741038303Peel-Apart Percutaneous Introducer Kit060115006011502016-02-22
00801741038310Peel-Apart Percutaneous Introducer Kit060116506011652016-02-22
00801741038327Peel-Apart Percutaneous Introducer Kit060117006011702016-02-22
00801741038334Peel-Apart Percutaneous Introducer Kit060771006077102016-02-22
00801741038341Peel-Apart Percutaneous Introducer Kit060777006077702016-02-22
00801741038358Peel-Apart Percutaneous Introducer Kit060778006077802016-02-22
00801741038365MicroEZ Introducer067893506789352016-02-08
00801741038372MicroEZ Introducer067894506789452016-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741241055PowerPICC® Provena™ CatheterBard Access Systems, Inc.LJS2026-10-29
00801741241062PowerPICC® Provena™ CatheterBard Access Systems, Inc.LJS2026-10-29
00801741241024PowerPICC Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-10-21
00801741241031PowerPICC Provena Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-10-21
00801741241048PowerPICC Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-10-21
00886333209859L-Cath PICCARGON MEDICAL DEVICES, INC.LJS2026-10-14
10801902226119ARROWTELEFLEX INCORPORATEDLJS2026-10-07
10801902225907ARROWTELEFLEX INCORPORATEDLJS2026-10-06
10801902225631ARROWTELEFLEX INCORPORATEDLJS2026-08-18
10801902192025ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902194364ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902213188ARROWTELEFLEX INCORPORATEDLJS2026-07-23
10801902226171ARROWTELEFLEX INCORPORATEDLJS2026-07-06
00801741235207PowerPICCBard Access Systems, Inc.LJS2026-06-24
00801741235214PowerPICC ProvenaBard Access Systems, Inc.LJS2026-06-24
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
00860002238500Piccolo MedicalPiccolo Medical, Inc.LJS2026-05-06
00884908185386Vascu-PICC®Medical Components, Inc.LJS2025-11-20
00860002238531Piccolo MedicalPiccolo Medical, Inc.LJS2025-11-07
00860002238586Piccolo MedicalPiccolo Medical, Inc.LJS2025-11-07
10192253040241ArgyleCardinal Health 200, LLCLJS2025-01-08
10192253040258ArgyleCardinal Health 200, LLCLJS2025-01-08
10192253040265ArgyleCardinal Health 200, LLCLJS2025-01-08
15051684019880PASV MS KitAngiodynamics, Inc.LJS2024-10-18
15051684019897PASV MS KitAngiodynamics, Inc.LJS2024-10-18
15051684019903PASV MS KitAngiodynamics, Inc.LJS2024-10-18