FDA.reportPublic FDA data

HydroPICC Dual Lumen

Primary DI
00850030354044
Brand
HydroPICC Dual Lumen
Company
Access Vascular, Inc.
Model
80002002
Catalog number
80002002
Device description
HydroPICC 5Fr Dual Lumen Basic Kit (80cm GW)
Published
2022-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K213550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213550000HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.2022-05-04LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030354044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030354044008500303540448500303540440850030354044

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
085539114
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
00850030354167HydroMID80H061022025-11-18
00850030354174HydroMID80H061042025-11-18
00850030354426HydroMID MID-2512025-11-18
00850030354433HydroMID900061042025-11-18
00850030354471HydroPICCPICC-2522025-11-18
00850030354501HydroPICC80H021412025-11-18
00850030354518HydroPICC80H021422025-11-18
00850030354525HydroPICC80H021442025-11-18
00850030354396HydroPICC90001104900011042024-06-04
00850030354402HydroPICC Dual Lumen90002104900021042024-06-04
00850030354419HydroMID90004104900041042024-06-04
00850030354204HydroMID Basic Kit80004102800041022022-12-20
00850030354211HydroMID Maximal Barrier Kit80004104800041042022-12-20
00850030354280HydroPICC Basic Kit (130cm GW)80H0110180H011012023-12-19
00850030354297HydroPICC Basic Kit (70cm GW)80H0110280H011022023-12-19
00850030354310HydroPICC Dual Lumen 80H0210180H021012023-12-19
00850030354327HydroPICC Dual Lumen 80H0210280H021022023-12-19
00850030354341HydroMID Basic Kit80H0410280H041022023-12-19
00850030354303HydroPICC Maximal Barrier Kit80H0110480H011042023-11-30
00850030354334HydroPICC Dual Lumen 80H0210480H021042023-11-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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