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 ID17290015409107
NIH Device Record Keyd6c06282-7b6e-4a42-af1f-6a621a734ea8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAG100s control unit
Version Model NumberAG100s control unit
Catalog NumberHSAG100S01
Company DUNS514824387
Company NameHOSPITECH RESPIRATION LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97239191648
Emailinfo@cuffill.com
Phone+97239191648
Emailinfo@cuffill.com
Phone+97239191648
Emailinfo@cuffill.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015409100 [Primary]
GS117290015409107 [Package]
Contains: 07290015409100
Package: carton [1 Units]
In Commercial Distribution

FDA Product Code

BSKCuff, Tracheal Tube, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-03
Device Publish Date2019-03-23

Devices Manufactured by HOSPITECH RESPIRATION LTD

27290015409012 - AG Cuffill Kruuse - VET2019-04-03 The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringi
17290015409107 - AG100s control unit2019-04-03AnapnoGuard™ 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 unit2019-04-03 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 7.0mm2019-04-03 The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacu
27290015409159 - AnapnoGuard™ Endotracheal Tube 7.5mm2019-04-03 The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacu
27290015409166 - AnapnoGuard™ Endotracheal Tube 8.0mm2019-04-03 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

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