Vyaire

FDA UDI

Class I (US FDA UDI)

by Jaeger Medical GmbH

Identity

Trade Name: Vyaire FDA UDI
Generic Name: Breathing mouthpiece, reusable FDA UDI
Device Name: Large Nasal Probes FDA UDI
Model / Reference: 36-NPROBE04 FDA UDI
Description: Large Nasal Probes FDA UDI

Identifiers

Catalog Number: 36-NPROBE04 FDA UDI
Primary DI / UDI-DI: 14250892906864 FDA UDI
FDA Product Code: BYP FDA UDI
GMDN Term: Breathing mouthpiece, reusable 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

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, reusable

Vyaire by Jaeger Medical GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breathing mouthpiece, reusable.

Winx® — Apnicure, Inc. · Class II
Mouthpiece — SDI DIAGNOSTICS, INC. · Class II
BF — Allied Medical LLC · Class I
Itus Mouthguardz — SHINRIN-YOKU TRADERS LLC · Class II
Adapter, Tube, Sample Pack — A-M Systems, Inc. · Class I
AeroEclips*BAN* — MONAGHAN MEDICAL CORP. · Class II
Monaghan Medical Corporation — MONAGHAN MEDICAL CORP. · Class I
Adapter, Rubber, 1 3/8 TO 7/8 — 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

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

Manufacturer

Manufacturer: Jaeger Medical GmbH

Sources (1)

FDA UDI e7ca58cd-bef1-402d-b168-9b174cd06b4f 36 fields · synced May 30, 2026