Spirometer Bacterial/Viral Filter MC-850

GUDID 10858409005037

Medicomp

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• Primary Device ID: 10858409005037
• NIH Device Record Key: 98d72a9e-7073-496f-9b6a-207eaab76b86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirometer Bacterial/Viral Filter
• Version Model Number: MC-850
• Catalog Number: MC-850
• Company DUNS: 154454730
• Company Name: Medicomp
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858409005030 [Primary]
GS1	10858409005037 [Package]; Contains: 00858409005030; Package: case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851070

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-09-11

Devices Manufactured by Medicomp

• 10858409005631 - Pediatric HME: 2020-08-14
• 10858409005624 - Large Manual Percussor Cup; 89mm: 2020-04-30 Large Manual Percussor Cup; 89mm
• 10858409005280 - C02 Sampling Adapter: 2019-11-27
• 10858409005372 - Washington Tee: 2019-11-27
• 10858409005389 - C02 Sampling Adapter with Cap: 2019-11-27
• 00858409005009 - Adult Bacterial/Viral Filter: 2019-01-23
• 10858409005013 - Infant Bacterial/Viral Filter: 2019-01-23
• 00858409005023 - Nebulizer Bacteria Filter: 2019-01-23