Pft

FDA UDI

Class II (US FDA UDI)

by Vitalograph Ireland, Ltd.

Identity

Trade Name: PFT FDA UDI
Generic Name: Breathing mouthpiece, single-use FDA UDI
Device Name: 2820 PFT KIT 30/30 FDA UDI
Model / Reference: 2820 FDA UDI
Description: 2820 PFT KIT 30/30 FDA UDI

Identifiers

Primary DI / UDI-DI: 15099169284217 FDA UDI
510(k) Number: K942779 FDA UDI
FDA Product Code: BZG FDA UDI
GMDN Term: Breathing mouthpiece, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Category: Breathing mouthpiece, single-use

The PFT (Breathing mouthpiece) device is a designed for partial insertion into the patient's mouth to facilitate access to the respiratory system. It features a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse, typically attached to diagnostic and/or therapeutic respiratory devices.

Similar devices

Also classified as Breathing mouthpiece, single-use.

Astraguard — SDI DIAGNOSTICS, INC. · Class II
Mouthpiece, Disposable, .900"OD, 2.50" L — A-M Systems, Inc. · Class I
Mouthpiece, Disposable, 1.125" ID, 2.5" L — A-M Systems, Inc. · Class I
Disposable Mouthpiece 27mm OD — Vacumed · Class I
EasySpeak — Intersurgical Incorporated · Class I
All Flow Adult Disp Mthpc. — ALLIANCE TECH MEDICAL, INC. · Class I
Mouthpiece, Disposable, 3/4" O.D., 2.625" L — A-M Systems, Inc. · Class I
Mouthpiece, Disposable, 1-1/16" O.D., 2.625" L — A-M Systems, Inc. · Class I

Cleared under the same submission

K942779 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Vitalograph Ireland, Ltd.

Sources (1)

FDA UDI a60cb367-72f4-494f-9b21-3417d87b8b5c 35 fields · synced Jul 25, 2026