FDA.reportPublic FDA data

AG Connection KIT

Primary DI
07290015409117
Brand
AG Connection KIT
Company
HOSPITECH RESPIRATION LTD
Model
AG Connection KIT
Catalog number
AG100SHRNS1
Device description
AG Connection KIT 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.
Published
2019-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290015409114PackageGS110In Commercial Distribution
27290015409111PackageGS140In Commercial Distribution
07290015409117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001540911417290015409114
2729001540911127290015409111
07290015409117072900154091177290015409117

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube intubation-management systemAn electrically-powered, multi-purpose device assembly intended to sustain effective intubation of a patient using an endotracheal (ET) tube by: 1) inflating, monitoring, and maintaining inflation of the ET tube cuff; and 2) providing subglottic irrigation and aspiration; it may in addition be used for general-purpose airway clearance. It consists of an inflation pump, a pressure monitor, a carbon dioxide (CO2) sensor (to measure CO2 leaks around the cuff), an irrigation pump, a suction pump, and integrated controller.

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
+97239191648yoel@hospitech.co.il

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
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
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
16979264200000CuffTrekSHANGHAI LONGMANN TECH CO.,LTD.BSK2026-02-12
36979264200004CuffTrekSHANGHAI LONGMANN TECH CO.,LTD.BSK2026-01-23
03665023001112CuffGuardIDMEDBSK2025-12-19
03665023000948CuffGuardIDMEDBSK2025-12-19
03665023000955CuffGuardIDMEDBSK2025-12-19
03665023000962CuffGuardIDMEDBSK2025-12-19
03665023000979CuffGuardIDMEDBSK2025-12-19
03665023000986CuffGuardIDMEDBSK2025-12-19
03665023000993CuffGuardIDMEDBSK2025-12-19
03665023001020CuffGuardIDMEDBSK2025-12-19
03665023001068CuffGuardIDMEDBSK2025-12-19
03665023002515CuffGuardIDMEDBSK2025-12-19
03665023002522CuffGuardIDMEDBSK2025-12-19
03665023002539CuffGuardIDMEDBSK2025-12-19
03665023002546CuffGuardIDMEDBSK2025-12-19
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