HydroPICC Dual Lumen 80002002

GUDID 00850030354044

HydroPICC 5Fr Dual Lumen Basic Kit (80cm GW)

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: 00850030354044
• NIH Device Record Key: 997d243d-dc95-4500-a692-59f880dd410f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroPICC Dual Lumen
• Version Model Number: 80002002
• Catalog Number: 80002002
• 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	00850030354044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213550

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: 2022-07-22
• Device Publish Date: 2022-07-14

On-Brand Devices [HydroPICC Dual Lumen ]

• 00850030354068: HydroPICC Dual Lumen – Maximal Barrier Kit
• 00850030354044: HydroPICC 5Fr Dual Lumen Basic Kit (80cm GW)
• 00850030354037: HydroPICC 5Fr Dual Lumen Basic Kit (130cm GW)
• 00850030354273: HydroPICC Marked 5Fr Dual Lumen Maximal Barrier Kit
• 00850030354266: HydroPICC Marked 5Fr Dual Lumen Basic Kit (80cm GW)
• 00850030354259: HydroPICC Marked 5Fr Dual Lumen Basic Kit (130cm GW)
• 00850030354334: HydroPICC Marked 5Fr Dual Lumen Maximal Barrier Kit
• 00850030354327: HydroPICC Marked 5Fr Dual Lumen Basic Kit (70cm GW)
• 00850030354310: HydroPICC Marked 5Fr Dual Lumen Basic Kit (130cm GW)