HydroMID Full Kit 80004003

GUDID 00850030354013

Midline Catheter (Full Kit)

ACCESS VASCULAR, INC.

Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter

• Primary Device ID: 00850030354013
• NIH Device Record Key: da572bd9-1d90-4ec6-9d49-123433d8eebf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroMID Full Kit
• Version Model Number: 80004003
• Catalog Number: 80004003
• 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	00850030354013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203069

FDA Product Code

• FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less 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: 2021-10-25
• Device Publish Date: 2021-10-15

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): 2023-12-27 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)