FDA.reportPublic FDA data

Biowy PICC Catheter S Kit

Primary DI
00851739007163
Brand
Biowy PICC Catheter S Kit
Company
Biowy Corporation
Model
PICC5DK-S
Device description
PICC 5F Dual Lumen Catheter S Kit
Published
2021-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192246000Biowy PICC Catheter S KitBiowy Corporation2020-04-30LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851739007217PackageGS15In Commercial Distribution
00851739007224PackageGS14In Commercial Distribution
00851739007163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851739007217008517390072178517390072170851739007217
00851739007224008517390072248517390072240851739007224
00851739007163008517390071638517390071630851739007163

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033858426
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851739007040Biowy PICC CatheterPICC4SK2026-04-20
00851739007057Biowy PICC CatheterPICC5DK2026-04-20
00851739007064Biowy Tym TubeTT2026-04-20
00851739007026Biowy Freezing BagFB5002021-05-24
00851739007033Biowy Freezing BagFB10002021-05-24
00851739007002Biowy Freezing BagFB502021-05-24
00851739007019Biowy Freezing BagFB2502021-05-24
00851739007248Biowy Freezing BagFB5002021-05-24
00851739007255Biowy Freezing BagFB10002021-05-24
00851739007156Biowy PICC Catheter S KitPICC4SK-S2021-05-24

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
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H787MRC3S9150C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9160C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S920C3 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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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