VixOne™ Nebulizer Kit R-8420S

GUDID 50628725098505

MASK VIXONE NEBULIZER SMALL ADLT W/ 7' SAFLO OXYGEN TUBING

Canadian Hospital Specialties Limited

Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated
Primary Device ID50628725098505
NIH Device Record Keye90afa9e-e519-4cd4-b06a-5ad43ca56c30
Commercial Distribution StatusIn Commercial Distribution
Brand NameVixOne™ Nebulizer Kit
Version Model NumberR-8420S
Catalog NumberR-8420S
Company DUNS240992693
Company NameCanadian Hospital Specialties Limited
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com
Phone905-825 9300
Emailregulatory.affairs@chsltd.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100628725098500 [Primary]
GS150628725098505 [Package]
Contains: 00628725098500
Package: Corrugate Case [25 Units]
In Commercial Distribution

FDA Product Code

CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-09-13
Device Publish Date2023-06-15

On-Brand Devices [VixOne™ Nebulizer Kit]

50628725098505MASK VIXONE NEBULIZER SMALL ADLT W/ 7' SAFLO OXYGEN TUBING
50628725098239NEBULIZER VIXONE ADULT AEROSOL MASK 7' SAFLO OXYGEN TUBING
50628725098215NEBULIZER VIXONE T PIECE MOUTHPIECE 7' SAFLO TUBING 6' CORRUGATED TUBING
50628725097478NEBULIZER VIXONE

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