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Ulti-Mist

FDA UDI

Class I (US FDA UDI)

by King Systems Corporation.

Identity

Trade Name
Ulti-Mist FDA UDI
Generic Name
Heat/moisture exchanger, single-use FDA UDI
Device Name
HME ULTI-MIST TRACH VALVE O2 FDA UDI
Model / Reference
MS-133 FDA UDI
Description
HME ULTI-MIST TRACH VALVE O2 FDA UDI

Identifiers

Catalog Number
MS-133 FDA UDI
Primary DI / UDI-DI
00612649212487 FDA UDI
FDA Product Code
BYD FDA UDI
GMDN Term
Heat/moisture exchanger, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 12.5 Milliliter FDA UDI
Weight — 5.7 Gram FDA UDI

Category: Heat/moisture exchanger, single-use

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

Similar devices

Also classified as Heat/moisture exchanger, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
King Systems Corporation.

Sources (1)

  • FDA UDI b37f7cb1-46ba-4746-a04d-6e645c3f00af 36 fields · synced Jun 8, 2026