HydroPICC Basic Kit (130cm GW) 80001101

GUDID 00850030354228

Peripherally Inserted Central Marked Catheter (Basic Kit with 130cm GW)

ACCESS VASCULAR, INC.

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• Primary Device ID: 00850030354228
• NIH Device Record Key: 06fdaffb-0f28-45ea-bf7f-0e362ac0cb4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroPICC Basic Kit (130cm GW)
• Version Model Number: 80001101
• Catalog Number: 80001101
• 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	00850030354228 [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: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [HydroPICC Basic Kit (130cm GW)]

• 00862559000456: Peripherally Inserted Central Catheter (Basic Kit with 130cm GW)
• 00850030354228: Peripherally Inserted Central Marked Catheter (Basic Kit with 130cm GW)
• 00850030354280: Peripherally Inserted Central Marked Catheter (Basic Kit with 130cm GW)