VitaloLAB

GUDID 05099169915107

9100 VITALOGRAPH VitaloLAB (En)

VITALOGRAPH (IRELAND) LIMITED

Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult 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

• 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)
• 05099169915107 - VitaloLAB: 2022-11-229100 VITALOGRAPH VitaloLAB (En)
• 05099169915107 - VitaloLAB: 2022-11-22 9100 VITALOGRAPH VitaloLAB (En)