Aerdilx

FDA UDI

Class II (US FDA UDI)

by Platinum Exports Pty Ltd

Identity

Trade Name: Aerdilx FDA UDI
Generic Name: Nebulizing system delivery set, reusable FDA UDI
Device Name: Compressor Nebulizer Machine White Full UDI: (01)00860004038115(11)200701(10)120205006 FDA UDI
Model / Reference: white FDA UDI
Description: Compressor Nebulizer Machine White Full UDI: (01)00860004038115(11)200701(10)120205006 FDA UDI

Identifiers

Catalog Number: MCN-S600MD FDA UDI
Primary DI / UDI-DI: 00860004038115 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Nebulizing system delivery set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 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

Yes

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Nebulizing system delivery set, reusable

Aerdilx by Platinum Exports Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nebulizing system delivery set, reusable.

Omron Nosepiece for Nebulizer — Omron Healthcare, Inc. · Class II
Nasoneb® — MONAGHAN MEDICAL CORP. · Class I
Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
Nebulizer Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
Schuco — Allied Medical LLC · Class II
Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II
VixOne™ Reusable Nebulizer — WESTMED, INC. · Class II
Trek S — PARI RESPIRATORY EQUIPMENT, INC. · 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 II	Pending data

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Manufacturer

Manufacturer: Platinum Exports Pty Ltd

Sources (1)

FDA UDI 3596c687-31a4-4a0a-a862-ab51cbd61e0d 34 fields · synced May 30, 2026