Biowy PICC Catheter S Kit

GUDID 00851739007163

PICC 5F Dual Lumen Catheter S Kit

Biowy Corporation

Peripherally-inserted central venous catheter

• Primary Device ID: 00851739007163
• NIH Device Record Key: 507ebff4-a07c-434d-9029-b994a4f34f21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biowy PICC Catheter S Kit
• Version Model Number: PICC5DK-S
• Company DUNS: 033858426
• Company Name: Biowy Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851739007163 [Primary]
GS1	00851739007217 [Package]; Package: Inner Box [5 Units]; In Commercial Distribution
GS1	00851739007224 [Package]; Contains: 00851739007217; Package: Outer Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192246

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: 2021-06-01
• Device Publish Date: 2021-05-24

On-Brand Devices [Biowy PICC Catheter S Kit]

• 00851739007163: PICC 5F Dual Lumen Catheter S Kit
• 00851739007156: PICC 4F Single Lumen Catheter S Kit