AG Cuffill (mmHg)

FDA UDI

Class II (US FDA UDI)

by Hospitech Respiration Ltd

Identity

Trade Name: AG Cuffill (mmHg) FDA UDI
Generic Name: Endotracheal tube cuff inflator FDA UDI
Device Name: The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways. FDA UDI
Model / Reference: HSCUFF0031 FDA UDI
Description: The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways. FDA UDI

Identifiers

Catalog Number: HSCUFF0031 FDA UDI
Primary DI / UDI-DI: 07290015409032 FDA UDI
510(k) Number: K122721 FDA UDI
FDA Product Code: BSK FDA UDI
GMDN Term: Endotracheal tube cuff inflator 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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 cuff inflator

AG Cuffill (mmHg) by Hospitech Respiration Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endotracheal tube cuff inflator.

Venner™ Tracheal Seal Monitor — VENNER MEDICAL (SINGAPORE) PTE. LTD. · Class II
Cuffix — Biovo Technologies , Ltd. · Class II
RUSCH — TELEFLEX INCORPORATED · Class II
AincA® — Anesthesia Associates, Inc. · Class II
IntelliCuff — HAMILTON MEDICAL, INC. · Class II
TRACOE technic — Tracoe medical GmbH · Class II
Ambu A/S — VBM Medizintechnik GmbH · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II

Cleared under the same submission

K122721 also covers:

AG Cuffill Kruuse - VET — HOSPITECH RESPIRATION LTD

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 1ea1c4e7-f4bf-4c8a-a11f-7aef4dc8ed0d 37 fields · synced May 30, 2026