Pneumotrac

GUDID 05099169777576

6800 PNEUMOTRAC HARDWARE ONLY US

VITALOGRAPH (IRELAND) LIMITED

Diagnostic spirometer

• Primary Device ID: 05099169777576
• NIH Device Record Key: 4ff36283-6ce6-416c-ae26-a7ab1d226a16
• 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	05099169777576 [Package]; Contains: 15099169777573; Package: [1 Units]; In Commercial Distribution
GS1	15099169777573 [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: 2021-04-26
• Device Publish Date: 2021-04-16

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)