AG Cuffill (cmH2O) HSCUFF0041

GUDID 27290015409005

The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways.

HOSPITECH RESPIRATION LTD

Endotracheal tube cuff inflator
Primary Device ID27290015409005
NIH Device Record Key0bcbf51d-bb17-4af1-8e3e-b457e2e24ab1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAG Cuffill (cmH2O)
Version Model NumberHSCUFF0041
Catalog NumberHSCUFF0041
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97239191648
Emailinfo@cuffill.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015409001 [Primary]
GS117290015409008 [Package]
Contains: 07290015409001
Package: Carton [10 Units]
In Commercial Distribution
GS127290015409005 [Package]
Contains: 17290015409008
Package: Carton [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSKCuff, Tracheal Tube, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-21
Device Publish Date2016-09-16

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 unit2019-04-03 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) 2019-03-21The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways.
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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