Respironics Domed (Gherkin)

GUDID 25060120952534

GVS FILTER TECHNOLOGY UK LTD

Microbial medical gas filter, non-sterile, single-use

• Primary Device ID: 25060120952534
• NIH Device Record Key: c219ac7c-7857-4ace-8613-fa4d54ecc671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respironics Domed (Gherkin)
• Version Model Number: 3400/01AIUA058/0001
• 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
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• 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	15060120952537 [Primary]
GS1	25060120952534 [Package]; Contains: 15060120952537; Package: Box [150 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040712

FDA Product Code

• MOD: Accessory To Continuous Ventilator (Respirator)

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

• 15060120959710 - Smoke Set: 2024-08-09 The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing
• 15060120959772 - Smoke Gas Evacuation Tube Set: 2024-08-09 The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing
• 15060120959727 - Insufflation Set: 2024-08-08 To be used in conjunction with insufflators for intra-abdominal insufflation. Single use, disposable device.
• 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