Mouthpiece

FDA UDI

Class I (US FDA UDI)

by Sdi Diagnostics, Inc.

Identity

Trade Name: Mouthpiece FDA UDI
Generic Name: Breathing mouthpiece, single-use FDA UDI
Model / Reference: Accurette FDA UDI

Identifiers

Catalog Number: 29-8060-050 FDA UDI
Primary DI / UDI-DI: B279S298060050 FDA UDI
FDA Product Code: BYP FDA UDI
GMDN Term: Breathing mouthpiece, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5620 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Breathing mouthpiece, single-use

Mouthpiece by Sdi Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breathing mouthpiece, single-use.

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
PFT — Vitalograph Ireland, Ltd. · Class II
Disposable Mouthpiece 27mm OD — Vacumed · Class I
EasySpeak — Intersurgical Incorporated · Class I
All Flow Adult Disp Mthpc. — ALLIANCE TECH MEDICAL, INC. · Class I
PFT — Vitalograph Ireland, Ltd. · Class II
Mouthpiece, Disposable, 3/4" O.D., 2.625" L — A-M Systems, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Sdi Diagnostics, Inc.

Sources (1)

FDA UDI 89612ae9-fe50-4c6f-a3e0-196b5e84ecb7 33 fields · synced May 31, 2026