CuffGuard

GUDID 03665023002546

Power supply (Type A) generation 2

IDMED

Endotracheal tube cuff inflator

• Primary Device ID: 03665023002546
• NIH Device Record Key: b79e9ba6-0177-4ba4-97f4-c79bcab1b81b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CuffGuard
• Version Model Number: PWR5-U_US
• Company DUNS: 260233256
• Company Name: IDMED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665023002546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243562

FDA Product Code

• BSK: Cuff, Tracheal Tube, Inflatable

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [CuffGuard]

• 03665023002546: Power supply (Type A) generation 2
• 03665023002539: Power supply (Type G) generation 2
• 03665023002522: Power supply (Type C) generation 2
• 03665023002515: Power supply (Type I) generation 2
• 03665023001068: Box of 10 connecting tubes
• 03665023001020: CuffGuard complete kit (Main Unit, User manual, 1 tube, clamp for tube and bar, power supply, an
• 03665023000993: Power supply (Type I) generation 1
• 03665023000986: Power supply (Type A) generation 1
• 03665023000979: Power supply (Type G) generation 1
• 03665023000962: Power supply (Type C) generation 1
• 03665023000955: CuffGuard main unit (branded Draeger)
• 03665023000948: CuffGuard main unit (branded Idmed)