Spiration Valve System

GUDID 00896506002125

Airway Sizing Kit

Gyrus Acmi, Inc.

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• Primary Device ID: 00896506002125
• NIH Device Record Key: e9149823-bfd2-42a4-9f48-61c9c7ac62c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiration Valve System
• Version Model Number: HUS-SK
• Company DUNS: 117521967
• Company Name: Gyrus Acmi, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896506002125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H060002

FDA Product Code

• OAZ: One-Way Air-Leak Valve

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-04
• Device Publish Date: 2014-09-23

On-Brand Devices [Spiration Valve System]

• 00896506002217: Airway Sizing Kit
• 00896506002200: Valve in Cartridge, 9mm
• 00896506002187: Deployment Catheter and Loader, 2.6
• 00896506002125: Airway Sizing Kit
• 00896506002118: Deployment Catheter and Loader, 2.6
• 00896506002101: Valve in Cartridge, 7mm
• 00896506002095: Valve in Cartridge, 6mm
• 00896506002088: Valve in Cartridge , 5mm