Sentri™ Intersurgical EcoLite™ adult, mask with CO2 monitoring line

GUDID 00816472023719

Sentri™ Intersurgical EcoLite™ adult, mask with CO2 monitoring line for Microstream capnography, filter and tube, 2.1m

Intersurgical Incorporated

Rebreathing oxygen face mask

• Primary Device ID: 00816472023719
• NIH Device Record Key: c3dc385d-e93c-4a1b-b24c-512b81edfcd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentri™ Intersurgical EcoLite™ adult, mask with CO2 monitoring line
• Version Model Number: 11416500
• 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	00816472023702 [Primary]
GS1	00816472023719 [Package]; Contains: 00816472023702; Package: [25 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: 2023-01-03

Devices Manufactured by Intersurgical Incorporated

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• 05030267045884 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M: 2025-04-24 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M
• 05030267001804 - TRACHEOSTOMY MASK, PAEDIATRIC: 2025-04-23 TRACHEOSTOMY MASK, PAEDIATRIC
• 05030267098088 - PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M: 2025-04-23 PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M
• 05030267165285 - 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE: 2025-04-23 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M
• 00816472022552 - Nose Clip with Padding: 2025-04-22 Nose Clip with Padding
• 05030267161546 - 22mm Compact breathing system: 2025-04-22 22mm Compact breathing system with 3L bag, elbow, monitoring line, anesthetic face mask and HMEF >3m
• 05030267161751 - 22mm Compact breathing system: 2025-04-22 22mm Compact breathing system with 3L bag, monitoring line, HMEF, and Clearlite facemask >3 m