Identity
- Trade Name
- AG Connection KIT FDA UDI
- Generic Name
- Endotracheal tube intubation-management system FDA UDI
- Device Name
- AG100s(KIT) EUDAMEDAG 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. FDA UDI
- Model / Reference
- AG100s (KIT) EUDAMEDAG100SHRNS1 EUDAMEDAG Connection KIT FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- AG100SHRNS1 FDA UDI
- Primary DI / UDI-DI
- D-729001540911A2MU EUDAMED07290015409117 FDA UDI
- Basic UDI-DI
- B-729001540911A2MU EUDAMED
- FDA Product Code
- BSK FDA UDI
- EMDN Code
- R01038001 ENDOTRACHEAL TUBE CUFFS INFLATION SYSTEMS EUDAMED
- GMDN Term
- Endotracheal tube intubation-management system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
AG100s(KIT) by Hospitech Respiration Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-729001540911A2MU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hospitech Respiration Ltd.
- EUDAMED SRN
- IL-MF-000018143
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED e7d5531f-eed9-4adb-95a9-333fe91d9b18 61 fields · synced Jul 22, 2026
- FDA UDI 4b48729f-32ab-4276-9824-f212dd2f76a7 36 fields · synced May 30, 2026