HydroPICC 90001104

GUDID 00850030354396

4F Peripherally Inserted Central Marked Catheter (Mobile Kit)

Access Vascular, Inc.

General surgical procedure kit, medicated

• Primary Device ID: 00850030354396
• NIH Device Record Key: ed6fe347-8b69-4545-bfef-798c13fa52b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroPICC
• Version Model Number: 90001104
• Catalog Number: 90001104
• 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	00850030354396 [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: 2024-06-12
• Device Publish Date: 2024-06-04

On-Brand Devices [HydroPICC]

• 00862559000401: HydroPICC - 4F x 55cm Catheter Kit
• 00862559000418: Peripherally Inserted Central Catheter
• 00862559000425: Peripherally Inserted Central Catheter (IR kit with 80cm guidewire)
• 00850030354396: 4F Peripherally Inserted Central Marked Catheter (Mobile Kit)