HydroPICC Basic Kit (70cm GW) 80H01102

GUDID 00850030354297

Peripherally Inserted Central Marked Catheter (Basic Kit with 70cm GW)

ACCESS VASCULAR, INC.

General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated

• Primary Device ID: 00850030354297
• NIH Device Record Key: 0133b0e6-d4ab-4907-a00b-be36dfba2dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroPICC Basic Kit (70cm GW)
• Version Model Number: 80H01102
• Catalog Number: 80H01102
• Company DUNS: 085539114
• Company Name: ACCESS VASCULAR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030354297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193015

FDA Product Code

• LJS: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-27
• Device Publish Date: 2023-12-19

Devices Manufactured by ACCESS VASCULAR, INC.

• 00850030354204 - HydroMID Basic Kit: 2024-02-08 Midline Marked Catheter (Basic Kit)
• 00850030354211 - HydroMID Maximal Barrier Kit: 2024-02-08 Midline Marked Catheter (Maximal Barrier Kit)
• 00850030354280 - HydroPICC Basic Kit (130cm GW): 2023-12-27 Peripherally Inserted Central Marked Catheter (Basic Kit with 130cm GW)
• 00850030354297 - HydroPICC Basic Kit (70cm GW): 2023-12-27Peripherally Inserted Central Marked Catheter (Basic Kit with 70cm GW)
• 00850030354297 - HydroPICC Basic Kit (70cm GW): 2023-12-27 Peripherally Inserted Central Marked Catheter (Basic Kit with 70cm GW)
• 00850030354310 - HydroPICC Dual Lumen: 2023-12-27 HydroPICC Marked 5Fr Dual Lumen Basic Kit (130cm GW)
• 00850030354327 - HydroPICC Dual Lumen: 2023-12-27 HydroPICC Marked 5Fr Dual Lumen Basic Kit (70cm GW)
• 00850030354341 - HydroMID Basic Kit: 2023-12-27 Midline Marked Catheter (Basic Kit)
• 00850030354303 - HydroPICC Maximal Barrier Kit: 2023-12-08 Peripherally Inserted Central Marked Catheter (Maximal Barrier Kit)