Ulti-MistHME/F Child MS-101

GUDID 00612649181776

HME/F ULTI-MIST CHILD

King Systems Corporation

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID00612649181776
NIH Device Record Key47eecbdc-0fb8-476c-8488-e42dea984706
Commercial Distribution StatusIn Commercial Distribution
Brand NameUlti-MistHME/F Child
Version Model NumberMS-101
Catalog NumberMS-101
Company DUNS009299017
Company NameKing Systems Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com

Device Dimensions

Weight9.5 Gram
Weight9.5 Gram
Weight9.5 Gram
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram
Total Volume15 Milliliter
Weight9.5 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS100612649181776 [Package]
Contains: 00612649205144
Package: [50 Units]
In Commercial Distribution
GS100612649205144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, bacterial, breathing-circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-04
Device Publish Date2016-09-22

Devices Manufactured by King Systems Corporation

00612649100494 - CORRUGATED TUBING2026-01-30 TUBING,100' SEGMENTED COIL
00612649185224 - WASHINGTON CONNECTOR2026-01-30 CUSTOM ACCESSORY
00612649106779 - 100 FT 22MM ULTRA FLEX® TUBING2026-01-30 TUBING 100 ULTRAFLEX COIL
00612649121758 - 100 FT., 6" 22MM SEGMENTED2026-01-30 TUBING 100 SEGMENTED COIL
00612649149103 - RE'SPOSABLE® F2®2026-01-30 RESPOSABLE F2 PLASTIC MANIFOLD
00612649154114 - 18" REUSABLE TUBING2026-01-30 TUBING,18"REUSEABLE CREAM
00612649190242 - BREATHING BAG2026-01-30 BREATHING BAG,3L,NEOPRENE
00612649190181 - BREATHING BAG2026-01-30 BREATHING BAG,1/2L,NEOPRENE

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.