Atmos 1A-AC

GUDID 00850030696007

For Bladder Pressure

Gemini Medical Technologies LLC

Urodynamic manometric catheter, non-electronic

• Primary Device ID: 00850030696007
• NIH Device Record Key: a3d2d2f0-2fd8-4765-99b6-4f4ffc8115e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atmos
• Version Model Number: Single Sensor Abdominal Air-Charged Urodynamics Ca
• Catalog Number: 1A-AC
• Company DUNS: 125832371
• Company Name: Gemini Medical Technologies LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com
• Phone: 833.943.6464
• Email: bhersh@geminimedtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030696007 [Primary]
GS1	10850030696011 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• FEN: Device, Cystometric, Hydraulic

Sterilization

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

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

[00850030696007]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-04
• Device Publish Date: 2024-05-27

On-Brand Devices [Atmos]

• 00850030696069: For Bladder Pressure
• 00850030696021: For Bladder Pressure
• 00850030696007: For Bladder Pressure
• 00850030696045: For Bladder Pressure