FDA.reportPublic FDA data

AG Cuffill (cmH2O)

Primary DI
07290015409001
Brand
AG Cuffill (cmH2O)
Company
HOSPITECH RESPIRATION LTD
Model
HSCUFF0041
Catalog number
HSCUFF0041
Device description
The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSKCuff, Tracheal Tube, Inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSKCuff, Tracheal Tube, InflatableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122721000AG GUFFILLHospitech Respiration , Ltd.2013-05-03BSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290015409008PackageGS110In Commercial Distribution
27290015409005PackageGS1200In Commercial Distribution
07290015409001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001540900817290015409008
2729001540900527290015409005
07290015409001072900154090017290015409001

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube cuff inflatorA manually-powered device designed to instill air into the cuff of an in situ endotracheal (ET)/endobronchial tube. The inflator typically includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-32 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature-32 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+97239191648info@cuffill.com

Regulatory Flags#

DUNS number
514824387
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015409124AnapnoGuard™ Endotracheal Tube 7.0mmAnapnoGuard™ Endotracheal Tube 7.0mmETP70PUC12019-03-05
07290015409155AnapnoGuard™ Endotracheal Tube 7.5mmAnapnoGuard™ Endotracheal Tube 7.5mmETP75PUC12019-03-05
07290015409162AnapnoGuard™ Endotracheal Tube 8.0mmAnapnoGuard™ Endotracheal Tube 8.0mmETP80PUC12019-03-05
07290015409018AG Cuffill Kruuse - VETAG Cuffill Kruuse - VETHSCUFF00522019-03-05
07290015409100AG100s control unitAG100s control unitHSAG100S012019-03-23
07290015409117AG Connection KIT AG Connection KIT AG100SHRNS12019-03-23
27290015409012AG Cuffill Kruuse - VETAG Cuffill Kruuse - VETHSCUFF00522019-03-05
17290015409107AG100s control unitAG100s control unitHSAG100S012019-03-23
17290015409114AG Connection KIT AG Connection KIT AG100SHRNS12019-03-23
27290015409128AnapnoGuard™ Endotracheal Tube 7.0mmAnapnoGuard™ Endotracheal Tube 7.0mmETP70PUC12019-03-05
27290015409159AnapnoGuard™ Endotracheal Tube 7.5mmAnapnoGuard™ Endotracheal Tube 7.5mmETP75PUC12019-03-05
27290015409166AnapnoGuard™ Endotracheal Tube 8.0mmAnapnoGuard™ Endotracheal Tube 8.0mmETP80PUC12019-03-05
07290015409032AG Cuffill (mmHg) HSCUFF0031 HSCUFF0031 2016-09-16
27290015409005AG Cuffill (cmH2O) HSCUFF0041HSCUFF00412016-09-16
17290015409039AG Cuffill (mmHg) HSCUFF0031 HSCUFF0031 2016-09-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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