Ulti-MistHME/F ICU MS-121

GUDID 00612649181813

HME/F ULTI-MIST ICU

King Systems Corporation

Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter
Primary Device ID00612649181813
NIH Device Record Keyd302adb0-eb44-46a0-9730-1af39e21546a
Commercial Distribution StatusIn Commercial Distribution
Brand NameUlti-MistHME/F ICU
Version Model NumberMS-121
Catalog NumberMS-121
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

Device Dimensions

Total Volume95 Milliliter
Total Volume95 Milliliter
Total Volume95 Milliliter
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter
Weight45 Gram
Total Volume95 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100612649181813 [Package]
Contains: 00612649205199
Package: [50 Units]
In Commercial Distribution
GS100612649205199 [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

00612649163789 - UNIVERSAL FLEX2®2024-01-11 UNIVERSAL FLEX2 CIRCUIT
00612649182032 - King Vision Video Laryngoscope Reusable Display2023-11-17 Reusable, digital display, complete with video-out port and battery status LED indicator
00612649178073 - King Vision Video Laryngoscope Kit2023-11-17 King Vision Kit consisting of 1 Reusable digital display with video-out port and battery status LED indicator, 3 channeled dispo
00612649182094 - King Vision Video Laryngoscope Standard aBlade2023-11-17 King Vision - aBlades size 3 20 pcs. = 1 case
00612649182087 - King Vision Video Laryngoscope Channeled aBlade2023-11-17 King Vision - aBlades channeled, size 3 20 pcs. = 1 case
00612649182117 - King Vision Video Laryngoscope Adapter2023-11-17 aBlade video adapter 3-4 For King Vision
00612649208312 - Video laryngoscope reusable display and adapter2023-11-17 Display and Adapter Kit - for King Vision Includes 1 Display and 1 Adapter 3-4
00612649182100 - Video laryngoscope aBlade kit2023-11-17 King Vision aBlade Kit Complete with 1 Vision Display,4 channeled aBlades 2 standard aBlades, case and AAA batteries

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.