Mouthseal, Disposable, Blue Thermoplastic IPPB

FDA UDI

Class I (US FDA UDI)

by A-M Systems, Inc.

Identity

Trade Name: Mouthseal, Disposable, Blue Thermoplastic IPPB FDA UDI
Generic Name: Breathing mouthpiece, single-use FDA UDI
Device Name: Mouthseal, Disposable, Blue Thermoplastic IPPB FDA UDI
Model / Reference: Mouthseal,Blue Thermoplastic IPPB - 165200 FDA UDI
Description: Mouthseal, Disposable, Blue Thermoplastic IPPB FDA UDI

Identifiers

Catalog Number: 165200 FDA UDI
Primary DI / UDI-DI: 00817081024265 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

Yes

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

Yes

FDA UDI

Category: Breathing mouthpiece, single-use

Mouthseal, Disposable, Blue Thermoplastic IPPB by A-M Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breathing mouthpiece, single-use.

Astraguard — SDI DIAGNOSTICS, INC. · Class II
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
Nebulizer, pacifier — BESMED HEALTH BUSINESS CORP. · Class I
Safe-T-Way — Vitalograph Ireland, Ltd. · Class II

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

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

Manufacturer

Manufacturer: A-M Systems, Inc.

Sources (1)

FDA UDI 693317cc-cbc8-422b-9203-39106b469e99 35 fields · synced Jun 1, 2026