Capnovue

GUDID B1821001P503

SALTER LABS

Rebreathing oxygen face mask

• Primary Device ID: B1821001P503
• NIH Device Record Key: f72f393b-898f-419e-b812-e2bd61576b95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capnovue
• Version Model Number: 1001-P
• Company DUNS: 022721133
• Company Name: SALTER LABS
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (425) 406-6235
• Email: support@monitormask.com
• Phone: +1 (425) 406-6235
• Email: support@monitormask.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1821001P0 [Primary]
HIBCC	B1821001P503 [Package]; Contains: B1821001P0; Package: Shipper Box [50 Units]; In Commercial Distribution

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-19
• Device Publish Date: 2017-04-25

On-Brand Devices [Capnovue]

• B1824737TG70503: 2002-A 4737TG-7-0-50
• B1824737140503: 2004-A 4737-14-0-50
• B1824727TG70503: 1002-A 4727TG-7-0-50
• B18247271400: 1004-A 4727-14-0-50
• B1822001P0: 2001-P
• B1822001A503: 2001-A
• B1821001P503: 1001-P
• B1821001I0: 1001-I
• B1821001A0: 1001-A
• 10607411971393: CapnoVue Scope O2/CO2 Mask with reflective connector
• 10607411971386: CapnoVue Scope O2/CO2 Mask with reflective connector