VitaloLAB

GUDID 05099169915107

9100 VITALOGRAPH VitaloLAB (En)

VITALOGRAPH (IRELAND) LIMITED

Pulmonary function analysis system, adult

• Primary Device ID: 05099169915107
• NIH Device Record Key: 6c678b6f-26f4-410d-847f-d581f3429e36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitaloLAB
• Version Model Number: 9100
• Company DUNS: 219683489
• Company Name: VITALOGRAPH (IRELAND) LIMITED
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	05099169915107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221030

FDA Product Code

• BTY: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-22
• Device Publish Date: 2022-11-14

Devices Manufactured by VITALOGRAPH (IRELAND) LIMITED

• 05099169919105 - VitaloROV: 2024-08-08 9100 VITALOGRAPH VitaloROV (En)
• 15099169331898 - Mouthpiece: 2024-04-16 FRONT BITE-ON MOUTHPIECES
• 05099169916104 - VitaloQUB: 2023-06-19 9160 VITALOGRAPH VitaloQUB - EN
• 05099169830028 - IN2ITIVE: 2023-05-17 2120 In2itive
• 05099169688001 - SPIROTRAC: 2023-04-04 7000 SPIROTRAC
• 05099169673021 - COMPACT: 2023-02-20 6600 COMPACT
• 05099169673038 - COMPACT: 2023-02-20 6600 COMPACT RMS
• 05099169913103 - VitaloROV+: 2022-11-22 9100 VITALOGRAPH VitaloROV+ (En)