FDA.reportPublic FDA data

AG100s control unit

Primary DI
07290015409100
Brand
AG100s control unit
Company
HOSPITECH RESPIRATION LTD
Model
AG100s control unit
Catalog number
HSAG100S01
Device description
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.
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
17290015409107PackageGS11In Commercial Distribution
07290015409100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001540910717290015409107
07290015409100072900154091007290015409100

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
+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
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
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
10197344118441MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
10197344118458MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
20197344118448MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
20197344118455MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
10618125191533PoseyTIDI PRODUCTS, LLCBSK2024-05-03
20618125191530PoseyTIDI PRODUCTS, LLCBSK2024-05-03
00860010850909Pylant MonitorKal-Med, LLCBSK2023-09-01
06920687300870MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
06920687300887MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
06920687303604MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687300877MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687300884MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687303601MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
10889483002599SunMedSUNMED, LLCBSK2023-07-17
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBSK2023-04-19