Ulti-MistFilter

FDA UDI

Class II (US FDA UDI)

by King Systems Corporation.

Identity

Trade Name: Ulti-MistFilter FDA UDI
Generic Name: Microbial medical gas filter, single-use FDA UDI
Device Name: FILTER ULTI-MIST FDA UDI
Model / Reference: MS-112 FDA UDI
Description: FILTER ULTI-MIST FDA UDI

Identifiers

Catalog Number: MS-112 FDA UDI
Primary DI / UDI-DI: 00612649212449 FDA UDI
510(k) Number: K983817 FDA UDI
FDA Product Code: CAH FDA UDI
GMDN Term: Microbial medical gas filter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5260 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 37 Milliliter FDA UDI
Weight — 22 Gram FDA UDI

Category: Microbial medical gas filter, single-use

Ulti-MistFilter by King Systems Corporation. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microbial medical gas filter, single-use.

ECO slimline — GVS Filter Technology UK Ltd · Class IIa
Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Ventlab — Ventlab Corp. · Class II
Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
Ventlab — Ventlab Corp. · Class II
Pentair — Pentair Filtration Solutions · Class II
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II

Cleared under the same submission

K983817 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

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Manufacturer

Manufacturer: King Systems Corporation.

Sources (1)

FDA UDI 6ee5cb55-1a10-4053-b355-e8e723141581 37 fields · synced May 30, 2026