Wallaby 017 Micro Catheter

GUDID 06970908212024

The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter.

Shanghai Wallaby Medical Technologies Co., Inc.

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• Primary Device ID: 06970908212024
• NIH Device Record Key: cffa7e50-f53b-4d16-80ab-6c6b324250c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wallaby 017 Micro Catheter
• Version Model Number: MC1715090
• Company DUNS: 544535295
• Company Name: Shanghai Wallaby Medical Technologies Co., Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970908212024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223139

FDA Product Code

• KRA: Catheter, Continuous Flush

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: 2023-06-02
• Device Publish Date: 2023-05-25

On-Brand Devices [Wallaby 017 Micro Catheter]

• 06970908212024: The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen,
• 06970908212017: The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen,
• 06970908212000: The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen,