Microspacer, Bulk

Primary DI
10709078002714
Brand
Microspacer, Bulk
Company
WESTMED, INC.
Model
THS-BMS
Device description
Microspacer (Bulk)
Published
2017-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NVOSpacer, Direct Patient Interface

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVOSpacer, Direct Patient InterfaceAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078002714PackageGS1100In Commercial Distribution
00709078002717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800271410709078002714
00709078002717007090780027177090780027170709078002717

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078003028Composite Kit07932017-04-26
00709078003868Humidifier Adaptor04852017-05-26
00709078003899Composite Kit07942017-05-26
00709078005954OxyGo Bubble Humidifier1425-10142018-09-25
00709078007606Bubble Humidifier04802021-02-24
00709078014093Bubble Humidifier10022832022-03-31
00709078014277Bubble Humidifier010-1048582022-03-31
00709078014284Bubble Humidifier10022482022-03-31
00709078003011Composite Kit07922017-04-26
00709078003158Bubble Humidifier07952017-04-26
00709078003349Mod Kit Pulset™3362-912017-03-30
00709078003356Pulset3363-912017-03-30
00709078003974A-Line3100-302021-01-31
00709078004483Pulset3373-912017-08-31
00709078004612Pulset™ 1cc Syringe31002021-04-28
00709078005107Pulset™3165-912017-09-22
00709078006470Pulset3303-502022-05-31
00709078009082Pulset3173-142020-08-31
00709078011849A-Line3300-242020-09-30
00709078011863A-Line3100-202020-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00709078008566Earmates WESTMED, INC.NVO2020-06-02
10709078008563Earmates WESTMED, INC.NVO2020-06-02
00709078002717Microspacer, BulkWESTMED, INC.NVO2017-02-20