Easy Catcher

GUDID 10848340016599

Disposable Easy Catcher

ADVANCE MEDICAL DESIGNS, INC.

Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag

• Primary Device ID: 10848340016599
• NIH Device Record Key: eba193ee-be47-4d1a-9fae-fb1b99ac0afc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Catcher
• Version Model Number: O-EC52-JP
• Company DUNS: 130785884
• Company Name: ADVANCE MEDICAL DESIGNS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848340016592 [Primary]
GS1	10848340016599 [Package]; Contains: 00848340016592; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012168

FDA Product Code

• KKX: Drape, surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [Easy Catcher]

• 10848340010788: Disposable Easy Catcher
• 10848340013963: Disposable Easy Catcher
• 10848340016605: Disposable Easy Catcher
• 10848340016599: Disposable Easy Catcher