Pneumotrac

GUDID 05099169779723

6800 PNEUMOTRAC

VITALOGRAPH (IRELAND) LIMITED

Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional

• Primary Device ID: 05099169779723
• NIH Device Record Key: 65439cb8-600e-4c06-a2b4-7bf3ad37222a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneumotrac
• Version Model Number: 6800
• 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	05099169779723 [Package]; Contains: 15099169779720; Package: [1 Units]; In Commercial Distribution
GS1	15099169779720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142812

FDA Product Code

• BZG: SPIROMETER, DIAGNOSTIC

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: 2022-08-08
• Device Publish Date: 2022-07-31

On-Brand Devices [Pneumotrac]

• 05099169777330: MODEL 6800 INTRAC(1)
• 05099169777019: MODEL 6800 PNEUMOTRAC US(1)
• 05099169770010: 6800 PNEUMOTRAC USA
• 05099169777521: 6800 PNEUMOTRAC -C(1)
• 05099169777323: 6800 PNEUMOTRAC HARDWARE ONLY(1)
• 05099169770522: 6800 PNEUMOTRAC-C(1)
• 05099169770508: 6800 PNEUMOTRAC (HARDWARE ONLY)(1)
• 05099169777576: 6800 PNEUMOTRAC HARDWARE ONLY US
• 05099169779020: 6800 PNEUMOTRAC
• 05099169779723: 6800 PNEUMOTRAC
• 05099169779778: 6800 PNEUMOTRAC RMS (H/W ONLY)
• 05099169779570: 6800 PNEUMOTRAC (H/W ONLY)