PULMO-PROTECT™ LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP

GUDID 05030267160419

PULMO-PROTECT™ LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP

Intersurgical Incorporated

Pulmonary function testing kit Pulmonary function testing kit Pulmonary function testing kit Pulmonary function testing kit Pulmonary function testing kit Pulmonary function testing kit Pulmonary function testing kit Pulmonary function testing kit Pulmonary function testing kit

• Primary Device ID: 05030267160419
• NIH Device Record Key: 6dff5740-13cd-409c-a023-fbe895f33ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PULMO-PROTECT™ LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP
• Version Model Number: 1691053
• 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	05030267160402 [Primary]
GS1	05030267160419 [Package]; Contains: 05030267160402; Package: [30 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

Devices Manufactured by Intersurgical Incorporated

• 05030267166077 - VENTURI VALVE 24% OXYGEN, BLUE: 2024-04-12 VENTURI VALVE 24% OXYGEN, BLUE
• 05030267166145 - VENTURI VALVE 28% OXYGEN, WHITE: 2024-04-12 VENTURI VALVE 28% OXYGEN, WHITE
• 05030267166176 - VENTURI VALVE 35% OXYGEN, YELLOW: 2024-04-12 VENTURI VALVE 35% OXYGEN, YELLOW
• 05030267166206 - VENTURI VALVE 40% OXYGEN, RED: 2024-04-12 VENTURI VALVE 40% OXYGEN, RED
• 05030267166237 - VENTURI VALVE 60% OXYGEN, GREEN: 2024-04-12 VENTURI VALVE 60% OXYGEN, GREEN
• 05030267166268 - VENTURI VALVE 50% OXYGEN, PINK: 2024-04-12 VENTURI VALVE 50% OXYGEN, PINK
• 05030267166299 - VENTURI VALVE 31% OXYGEN, ORANGE: 2024-04-12 VENTURI VALVE 31% OXYGEN, ORANGE
• 05030267011674 - MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS: 2024-02-28 MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS