Urological Drainage Bag

GUDID 10848340020343

Urologic Drain Bag

ADVANCE MEDICAL DESIGNS, INC.

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• Primary Device ID: 10848340020343
• NIH Device Record Key: f99b8a60-4ce7-47fb-82c4-51ba82bf4f3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urological Drainage Bag
• Version Model Number: CC166NS
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848340020346 [Primary]
GS1	10848340020343 [Package]; Contains: 00848340020346; 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: 2024-03-26
• Device Publish Date: 2024-03-18

On-Brand Devices [Urological Drainage Bag]

• 10848340010023: Disposable Urological Drainage Device
• 10848340020343: Urologic Drain Bag
• 10848340020336: Urologic Drain Bag