AnapnoGuard™ Endotracheal Tube 8.0mm ETP80PUC1

GUDID 27290015409166

The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.

HOSPITECH RESPIRATION LTD

Basic endotracheal tube, single-use

• Primary Device ID: 27290015409166
• NIH Device Record Key: c7c71d83-563a-4c69-b616-642c290f2dca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnapnoGuard™ Endotracheal Tube 8.0mm
• Version Model Number: AnapnoGuard™ Endotracheal Tube 8.0mm
• Catalog Number: ETP80PUC1
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015409162 [Primary]
GS1	17290015409169 [Package]; Contains: 07290015409162; Package: carton [10 Units]; In Commercial Distribution
GS1	27290015409166 [Package]; Contains: 17290015409169; Package: carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093126

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-03
• Device Publish Date: 2019-03-05

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: 2019-04-03 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: 2019-04-03The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
• 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