FDA.reportPublic FDA data

Ulti-Mist

Primary DI
00612649140186
Brand
Ulti-Mist
Company
King Systems Corporation
Model
MS-102
Catalog number
MS-102
Device description
HME ULTI-MIST STRAIGHT
Published
2023-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYDCONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612649140186PackageGS150In Commercial Distribution
00612649205151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649140186006126491401866126491401860612649140186
00612649205151006126492051516126492051510612649205151

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-useA one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume25Milliliter
Weight11Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
009299017
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612649217604ADULT ULTRA FLEX®95509955092026-08-21
00612649217628PEDIATRIC ULTRA FLEX®96609966092026-08-21
00612649217642ADULT ULTRA FLEX®95510955102026-08-21
00612649217666ADULT ULTRA FLEX®95511955112026-08-21
00612649217680PEDIATRIC ULTRA FLEX®J21814-13621J21814-136212026-08-21
00612649217703PEDIATRIC ULTRA FLEX®J2904-13621J2904-136212026-08-21
00612649217727ADULT ULTRA FLEX®J81213F-13621J81213F-136212026-08-21
00612649196398ADULT ANESTHESIABREATHING CIRCUIT8403F-80Z8403F-80Z2016-09-22
00612649198552ADULT ANESTHESIA8600B-848600B-842020-10-21
00612649198651ADULT ANESTHESIABREATHING CIRCUIT8603F-6121Z8603F-6121Z2016-09-22
00612649198668ADULT ANESTHESIABREATHING CIRCUIT8603F-61Z8603F-61Z2016-09-22
00612649200033UNIVERSAL F2®C0120-230C0120-2302022-12-13
00612649200071UNIVERSAL F2®C060-230C060-2302023-01-16
00612649200118UNIVERSAL F2®C090-230C090-2302022-12-13
00612649200125UNIVERSAL F2®C090-61C090-612022-12-13
00612649200149UNIVERSAL F2®C360-61ZC360-61Z2022-12-13
00612649200323ADULT ANESTHESIABREATHING CIRCUITCP-01084CP-010842016-09-22
00612649200934UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD360-808ZD360-808Z2016-09-22
00612649201078UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD366-618ZD366-618Z2016-09-22
00612649201214UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-16421ZD395-16421Z2016-09-22

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Primary DI, Brand, Company table
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