Breather Med - cRMT

GUDID 00850021574345

McSc Medical, LLC

Incentive spirometer

• Primary Device ID: 00850021574345
• NIH Device Record Key: e0cacec1-03d3-4e7f-8bd1-0efaa9dca5fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breather Med - cRMT
• Version Model Number: B-Med
• Company DUNS: 118842370
• Company Name: McSc Medical, LLC
• Device Count: 1
• DM Exempt: false
• 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: 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	00850021574345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944412

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

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: 2024-09-17
• Device Publish Date: 2024-09-09

Devices Manufactured by McSc Medical, LLC

• 00850021574345 - Breather Med - cRMT: 2024-09-17
• 00850021574345 - Breather Med - cRMT: 2024-09-17
• 01240000013856 - Breather Med - cRMT Basic UDI: 2024-09-17