MedSource Sampling Cannula Not Applicable

GUDID 00840155413108

10’ Adult Nasal CO2 Sampling Cannula

MEDSOURCE INTERNATIONAL LLC

Carbon dioxide breath analyser

• Primary Device ID: 00840155413108
• NIH Device Record Key: 3163fdcf-f431-4d8f-99b9-4e2f133908e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Sampling Cannula
• Version Model Number: MS-35400A10
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840155413092 [Primary]
GS1	00840155413108 [Package]; Contains: 00840155413092; Package: Box [25 Units]; In Commercial Distribution
GS1	00840155413115 [Package]; Contains: 00840155413092; Package: Case [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143127

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 2022-06-01
• Device Publish Date: 2022-05-24

On-Brand Devices [MedSource Sampling Cannula]

• 00840155413139: 14’ Adult Nasal CO2 Sampling Cannula
• 00840155413108: 10’ Adult Nasal CO2 Sampling Cannula
• 00840155413078: 7’ Adult Nasal CO2 Sampling Cannula