FDA.report

Nebulizer

Primary DI
10709078000628
Brand
Nebulizer
Company
WESTMED, INC.
Model
0254
Device description
VixOneTM Nebulizer (Kit - Reusable)
Published
2016-11-24
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
false

Related Records

Product Codes

CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications

CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078000628PackageGS110In Commercial Distribution
00709078000621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800062810709078000628
00709078000621007090780006217090780006210709078000621

GMDN Terms

TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
false
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

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20889483562786Disposable Anesthesia Breathing Circuit 5705-S2024-09-06
20889483612009Anesthesia Circuit Kit R-60152024-05-31
20889483612016Anesthesia Circuit Kit R-66192024-05-31
20889483612023Anesthesia Circuit Kit R-68442024-05-31

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