Biowy PICC Catheter

Primary DI
00851739007040
Brand
Biowy PICC Catheter
Company
Biowy Corporation
Model
PICC4SK
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K173956000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173956000Biowy PlCC CatheterBiowy Corporation2018-05-21LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851739007040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851739007040008517390070408517390070400851739007040

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.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00851739007163Biowy PICC Catheter S KitPICC5DK-S2021-05-24

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Primary DI, Brand, Company table
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00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
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