HydroMID Maximal Barrier Kit 80004004

GUDID 00850030354020

Midline Catheter (Maximal Barrier 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: 00850030354020
• NIH Device Record Key: 6c7a078e-6d89-4e22-9bb1-e9f2aca4f5bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroMID Maximal Barrier Kit
• Version Model Number: 80004004
• Catalog Number: 80004004
• 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	00850030354020 [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

On-Brand Devices [HydroMID Maximal Barrier Kit]

• 00850030354020: Midline Catheter (Maximal Barrier Kit)
• 00850030354358: Midline Marked Catheter (Maximal Barrier Kit)
• 00850030354211: Midline Marked Catheter (Maximal Barrier Kit)