HydroPICC Maximal Barrier Kit 80H01104

GUDID 00850030354303

Peripherally Inserted Central Marked Catheter (Maximal Barrier Kit)

ACCESS VASCULAR, INC.

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• Primary Device ID: 00850030354303
• NIH Device Record Key: 3a26e82b-9139-45c0-b8de-f89c1d9cbf6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroPICC Maximal Barrier Kit
• Version Model Number: 80H01104
• Catalog Number: 80H01104
• 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	00850030354303 [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: 2023-12-08
• Device Publish Date: 2023-11-30

On-Brand Devices [HydroPICC Maximal Barrier Kit]

• 00862559000494: Peripherally Inserted Central Catheter (Maximal Barrier Kit)
• 00850030354242: Peripherally Inserted Central Marked Catheter (Maximal Barrier Kit)
• 00850030354303: Peripherally Inserted Central Marked Catheter (Maximal Barrier Kit)