Spiration Valve System

GUDID 00896506002309

Valve in Cartridge, 9mm

SPIRATION, INC.

Endobronchial valve

• Primary Device ID: 00896506002309
• NIH Device Record Key: 7439440f-8a88-449a-b517-f94cd71650c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiration Valve System
• Version Model Number: SVS-V9-00
• Company DUNS: 003664419
• Company Name: SPIRATION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Dimensions

• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896506002309 [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