Closed Monitoring System

GUDID 10848340019439

Fluid Delivery Set

ADVANCE MEDICAL DESIGNS, INC.

Surgical fluid/gas irrigator

• Primary Device ID: 10848340019439
• NIH Device Record Key: 33c00a41-6d0b-4220-ba41-8f62fb40f15d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Closed Monitoring System
• Version Model Number: 64-CMS03
• 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: 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	00848340019432 [Primary]
GS1	10848340019439 [Package]; Contains: 00848340019432; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900187

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

[10848340019439]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by ADVANCE MEDICAL DESIGNS, INC.

• 10848340010481 - Mitaka Drape: 2024-04-25 Disposable Equipment Cover
• 10848340011464 - Mitaka Spy Elite: 2024-04-25 Disposable Equipment Cover
• 10848340015530 - Rolled Probe Cover: 2024-04-24 Disposable Equipment Cover
• 10848340016834 - Rolled Probe Cover: 2024-04-24 Disposable Equipment Cover
• 10848340016858 - Rolled Probe Cover: 2024-04-24 Disposable Equipment Cover
• 10848340015547 - Rolled Probe Cover: 2024-04-23 Disposable Equipment Cover
• 10848340012089 - Sterile Elastic Bands: 2024-04-22 Sterile Elastic Bands
• 10848340015486 - C-Arm Pack: 2024-04-22 Disposable Equipment Cover