MedSource Nasal Cannula Not Applicable

GUDID 00840155408920

Pediatric Nasal/Oral Dual CO2 Sampling Cannula W/ O2 delivery

MEDSOURCE INTERNATIONAL LLC

Carbon dioxide breath analyser

• Primary Device ID: 00840155408920
• NIH Device Record Key: 2070a8c2-addf-4d7a-bbb0-27526ea3690c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Nasal Cannula
• Version Model Number: MS-35601P
• 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	00840155408913 [Primary]
GS1	00840155408920 [Package]; Contains: 00840155408913; Package: Box [25 Units]; In Commercial Distribution
GS1	00840155408937 [Package]; Contains: 00840155408913; 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: 2021-06-28
• Device Publish Date: 2021-06-18

On-Brand Devices [MedSource Nasal Cannula]

• 00816703026885: Nasal Cannula, Adult, Flared Tip
• 00816703026861: Nasal Cannula, Adult, Non-Flared Tip
• 00816703026847: Nasal Cannula, Adult, Non-Flared tip
• 00816703026823: Nasal Cannula, Adult, Non-Flared Tip
• 00816703029978: Soft Cannula, Pediatric, 7' Tubing
• 00816703029954: Soft Cannula, Adult, 7' Tubing
• 00816703029893: Nasal Cannula, Pediatric, Non-Flared Tips
• 00816703029879: Nasal Cannula, Adult, Non-Flared Tips, 50' Tubing
• 00816703026946: Nasal Cannula, Adult, 7', Univ. Conn.
• 00816703026922: Nasal Cannula, Adult, 25' Tubing
• 00816703026908: Nasal Cannula, Adult, 14' Tubing
• 00816703029992: Soft Cannula, Infant w/ Univ. Conn.
• 00840155408982: All Purpose Sampling Line with T-Connector
• 00840155408951: Adult Nasal/Oral Dual CO2 Sampling Cannula W/ O2 Delivery
• 00840155408920: Pediatric Nasal/Oral Dual CO2 Sampling Cannula W/ O2 delivery
• 00840155408890: Adult Nasal CO2 Sampling Cannula W/ O2 delivery