HydroPICC Full Kit 80001003

GUDID 00862559000487

Peripherally Inserted Central Catheter (Full Kit)

ACCESS VASCULAR, INC.

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• Primary Device ID: 00862559000487
• NIH Device Record Key: a40b879c-041f-4986-8dcc-f5a9514bc4ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroPICC Full Kit
• Version Model Number: 80001003
• Catalog Number: 80001003
• 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	00862559000487 [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: 2021-10-25
• Device Publish Date: 2021-10-15

On-Brand Devices [HydroPICC Full Kit]

• 00862559000487: Peripherally Inserted Central Catheter (Full Kit)
• 00862559000470: Peripherally Inserted Central Catheter (Full Kit)