PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP

GUDID 05030267135806

PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP

Intersurgical Incorporated

Pulmonary function testing kit

• Primary Device ID: 05030267135806
• NIH Device Record Key: 5139828f-50fb-49e2-ba1e-e84f3c955469
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP
• Version Model Number: 1691050
• 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	05030267135790 [Primary]
GS1	05030267135806 [Package]; Contains: 05030267135790; 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

On-Brand Devices [PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP]

• 05030267135806: PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP
• 05030267135714: PULMO-PROTECT LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP