PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE

GUDID 05030267160648

PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE

Intersurgical Incorporated

Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece

• Primary Device ID: 05030267160648
• NIH Device Record Key: 9f0408d3-11ee-4aa0-809f-80c204913965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE
• Version Model Number: 1691005
• Company DUNS: 785952607
• Company Name: Intersurgical Incorporated
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05030267160631 [Primary]
GS1	05030267160648 [Package]; Contains: 05030267160631; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013123

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2022-07-25
• Device Publish Date: 2022-07-15

On-Brand Devices [PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE]

• 05030267161027: PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE
• 05030267160648: PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE
• 05030267160594: PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE
• 05030267160570: PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE