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

• 05030267124084 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M
• 05030267124091 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M
• 05030267124107 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F
• 05030267123582 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F
• 05030267124121 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F
• 05030267124077 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F
• 05030267124138 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22F
• 05030267165322 - I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT: 2025-10-01 I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT