FDA.reportPublic FDA data

AnapnoGuard™ Endotracheal Tube 8.0mm

Primary DI
27290015409166
Brand
AnapnoGuard™ Endotracheal Tube 8.0mm
Company
HOSPITECH RESPIRATION LTD
Model
AnapnoGuard™ Endotracheal Tube 8.0mm
Catalog number
ETP80PUC1
Device description
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.
Published
2019-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093126000ANAPNOGUARD ENDOTRACHEAL TUBEHospitech Respiration , Ltd.2010-03-02BTP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290015409169PackageGS110In Commercial Distribution
27290015409166PackageGS1100In Commercial Distribution
07290015409162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001540916917290015409169
2729001540916627290015409166
07290015409162072900154091627290015409162

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
514824387
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07290015409001AG Cuffill (cmH2O) HSCUFF0041HSCUFF00412016-09-16
07290015409032AG Cuffill (mmHg) HSCUFF0031 HSCUFF0031 2016-09-16
27290015409005AG Cuffill (cmH2O) HSCUFF0041HSCUFF00412016-09-16
17290015409039AG Cuffill (mmHg) HSCUFF0031 HSCUFF0031 2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
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00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750471KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27