In2itive

GUDID 05099169796744

VIT. 2120 HANDHELD IN2ITIVE WITH SPIROMETRY + GPRS CRADLE

VITALOGRAPH (IRELAND) LIMITED

Diagnostic spirometer

• Primary Device ID: 05099169796744
• NIH Device Record Key: 5eced1c7-0e5a-420b-8c33-c7f188c16cdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In2itive
• Version Model Number: 2120
• 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	05099169796744 [Package]; Contains: 15099169796741; Package: [1 Units]; In Commercial Distribution
GS1	15099169796741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100687

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: 2021-07-26
• Device Publish Date: 2021-07-16

On-Brand Devices [In2itive]

• 05099169794016: 2120 HAND HELD IN2ITIVE US & VITALOGRAPH REPORTS (1)
• 05099169793019: 2120 HAND HELD IN2ITIVE US & PRINT CRADLE (1)
• 05099169790018: CASE 2120 HAND HELD VITALOGRAPH IN2ITIVE US (1)
• 05099169796799: VIT.2120 HANDHELD IN2ITIVE E-DIARY WITH PENTA BAND CRADLE
• 05099169796744: VIT. 2120 HANDHELD IN2ITIVE WITH SPIROMETRY + GPRS CRADLE
• 05099169790490: 2120 HAND HELD VITALOGRAPH IN2ITIVE - MICRO DIRECT
• 05099169830028: 2120 In2itive