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

GUDID 05030267135783

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

Intersurgical Incorporated

Pulmonary function testing kit

• Primary Device ID: 05030267135783
• NIH Device Record Key: 98fbc210-a7ee-4abd-974f-2d125b886244
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PULMO-PROTECT™ LUNG FUNCTION FILTER, FLEXIBLE MOUTHPIECE AND NOSE CLIP
• Version Model Number: 1691012
• 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	05030267135776 [Primary]
GS1	05030267135783 [Package]; Contains: 05030267135776; 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

• 05030267011872 - GAS MONITORING LINE, 1.2MM ID, MALE/MALE LUER LOCK, 3M: 2024-11-01 GAS MONITORING LINE, 1.2MM ID, MALE/MALE LUER LOCK, 3M
• 05030267163571 - INTERSURGICAL ECOLITE™, ADULT, HIGH CONCENTRATION OXYGEN MASK AND TUBE, 2.1M: 2024-10-17 INTERSURGICAL ECOLITE™, ADULT, HIGH CONCENTRATION OXYGEN MASK AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
• 05030267163588 - CIRRUS™2 NEBULISER MOUTHPIECE KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M: 2024-10-17 CIRRUS™2 NEBULISER MOUTHPIECE KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
• 05030267163618 - CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE, 2.1M: 2024-10-17 CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
• 05030267163595 - CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT AND TUBE, 2.1M: 2024-10-17 CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
• 05030267167142 - CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, 22F: 2024-10-17 CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, 22F
• 05030267167166 - CLEARLITE™ AIR, ANAESTHETIC FACE MASK SIZE 4 ADULT GREEN SEAL NO HOOK RING 22F: 2024-10-17 CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, NO HOOK RING, 22F
• 05030267040865 - 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M: 2024-09-24 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M