AG100s control unit

FDA UDI

Class II (US FDA UDI)

by Hospitech Respiration Ltd

Identity

Trade Name: AG100s control unit FDA UDI
Generic Name: Endotracheal tube intubation-management system FDA UDI
Device Name: 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. FDA UDI
Model / Reference: AG100s control unit FDA UDI
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. FDA UDI

Identifiers

Catalog Number: HSAG100S01 FDA UDI
Primary DI / UDI-DI: 07290015409100 FDA UDI
FDA Product Code: BSK FDA UDI
GMDN Term: Endotracheal tube intubation-management system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Endotracheal tube intubation-management system

AG100s control unit by Hospitech Respiration Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Hospitech Respiration Ltd

Sources (1)

FDA UDI d6c06282-7b6e-4a42-af1f-6a621a734ea8 36 fields · synced May 30, 2026