VitaloJAK

GUDID 05099169715103

Base VITALOJAK INTERNATIONAL WEST(1)

VITALOGRAPH (IRELAND) LIMITED

Cough ambulatory recording system Cough ambulatory recording system

• Primary Device ID: 05099169715103
• NIH Device Record Key: 654bd161-d12f-4d55-a65e-eeb14a097b4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitaloJAK
• Version Model Number: 7100
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169710214 [Package]; Contains: 15099169715100; Package: [1 Units]; In Commercial Distribution
GS1	05099169715103 [Package]; Contains: 15099169715100; Package: [1 Units]; In Commercial Distribution
GS1	15099169715100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110525

FDA Product Code

• DSH: RECORDER, MAGNETIC TAPE, MEDICAL

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: 2019-11-08
• Device Publish Date: 2018-05-17

On-Brand Devices [VitaloJAK]

• 05099169715103: Base VITALOJAK INTERNATIONAL WEST(1)
• 05099169710238: Base VITALOJAK - SHORT CABLE(1)
• 05099169710023: Base VitaloJAK UK(1)
• 05099169715110: Base VITALOJAK