AG100s control unit HSAG100S01

GUDID 17290015409107

AnapnoGuard™ 100 system is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.

HOSPITECH RESPIRATION LTD

Endotracheal tube intubation-management system

• Primary Device ID: 17290015409107
• NIH Device Record Key: d6c06282-7b6e-4a42-af1f-6a621a734ea8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AG100s control unit
• Version Model Number: AG100s control unit
• Catalog Number: HSAG100S01
• Company DUNS: 514824387
• Company Name: HOSPITECH RESPIRATION LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97239191648
• Email: info@cuffill.com
• Phone: +97239191648
• Email: info@cuffill.com
• Phone: +97239191648
• Email: info@cuffill.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015409100 [Primary]
GS1	17290015409107 [Package]; Contains: 07290015409100; Package: carton [1 Units]; In Commercial Distribution

FDA Product Code

• BSK: Cuff, Tracheal Tube, Inflatable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-03
• Device Publish Date: 2019-03-23

Devices Manufactured by HOSPITECH RESPIRATION LTD

• 27290015409012 - AG Cuffill Kruuse - VET: 2019-04-03 The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringi
• 17290015409107 - AG100s control unit: 2019-04-03AnapnoGuard™ 100 system is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.
• 17290015409107 - AG100s control unit: 2019-04-03 AnapnoGuard™ 100 system is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuf
• 17290015409114 - AG Connection KIT: 2019-04-03 AG Connection KIT is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff press
• 27290015409128 - AnapnoGuard™ Endotracheal Tube 7.0mm: 2019-04-03 The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacu
• 27290015409159 - AnapnoGuard™ Endotracheal Tube 7.5mm: 2019-04-03 The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacu
• 27290015409166 - AnapnoGuard™ Endotracheal Tube 8.0mm: 2019-04-03 The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacu
• 27290015409005 - AG Cuffill (cmH2O): 2019-03-21 The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringi
• 17290015409039 - AG Cuffill (mmHg): 2019-03-21 The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringi