Spiration Valve System

GUDID 00896506002316

Deployment Catheter and Loader, 2.6

SPIRATION, INC.

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• Primary Device ID: 00896506002316
• NIH Device Record Key: c918011e-33b1-439f-950c-c052d152e47d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiration Valve System
• Version Model Number: SVS-C26N-06
• Company DUNS: 003664419
• Company Name: SPIRATION, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896506002316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180007

FDA Product Code

• NJK: Valve, Pulmonary

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-29

On-Brand Devices [Spiration Valve System]

• 00896506002323: Airway Sizing Kit
• 00896506002316: Deployment Catheter and Loader, 2.6
• 00896506002309: Valve in Cartridge, 9mm
• 00896506002293: Valve in Cartridge, 6mm
• 00896506002286: Valve in Cartridge , 5mm
• 00896506002279: Valve in Cartridge, 7mm