Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line

GUDID 00816472021852

Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line with universal connector tube, 1.8m

Intersurgical Incorporated

Rebreathing oxygen face mask

• Primary Device ID: 00816472021852
• NIH Device Record Key: f2ccd3f4-96fc-46ec-85cc-d1990574376f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line
• Version Model Number: 11426100
• Company DUNS: 785952607
• Company Name: Intersurgical Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com
• Phone: 3154512900
• Email: support@intersurgicalinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816472021845 [Primary]
GS1	00816472021852 [Package]; Contains: 00816472021845; Package: [30 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-02-11
• Device Publish Date: 2023-01-10

On-Brand Devices [Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line]

• 05030267159413: SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE FOR M/S CAPNOGRAPHY, FILTER A
• 00816472021852: Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line with universal connector tube