Spiroguard

GUDID 35060120951671

GVS FILTER TECHNOLOGY UK LTD

Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece

• Primary Device ID: 35060120951671
• NIH Device Record Key: 9bf8051f-fdbd-4a62-a75e-5ebf2db4faa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiroguard
• Version Model Number: 2800/21BAUC001/0001
• Company DUNS: 769934225
• Company Name: GVS FILTER TECHNOLOGY UK LTD
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060120951677 [Primary]
GS1	25060120951674 [Package]; Contains: 15060120951677; Package: Inner box [50 Units]; In Commercial Distribution
GS1	35060120951671 [Package]; Contains: 25060120951674; Package: Outer box [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051712

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by GVS FILTER TECHNOLOGY UK LTD

• 15060120957747 - HEPA Ventilation Filter: 2020-07-06
• 25060120956297 - Multi-Vent: 2018-12-31
• 35060120950100 - ECO HMEF: 2018-07-06
• 35060120950773 - ECO Maxi Filter: 2018-07-06
• 35060120951671 - Spiroguard: 2018-07-06
• 35060120951671 - Spiroguard: 2018-07-06
• 35060120951961 - Neo-natal HMEF: 2018-07-06
• 15060120952476 - Multi-vent: 2018-07-06
• 15060120952483 - Multi-Vent: 2018-07-06