Pediatric Vari-vent mask R-2800S

GUDID 50628725095559

PEDIATRIC VARI-VENT Mask, 6 Jets - 24% to 50%, Aerosol Hood, 7FT Saflo Tube

Canadian Hospital Specialties Limited

Venturi oxygen face mask
Primary Device ID50628725095559
NIH Device Record Key1979c073-fd76-44dc-9d07-aa41c5c834e0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Vari-vent mask
Version Model NumberR-2800S
Catalog NumberR-2800S
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100628725095554 [Primary]
GS150628725095559 [Package]
Contains: 00628725095554
Package: Corrugate Case [50 Units]
In Commercial Distribution

FDA Product Code

BYFMask, Oxygen, Low Concentration, Venturi

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-24
Device Publish Date2024-05-16

Devices Manufactured by Canadian Hospital Specialties Limited

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00628725097169 - Oxygen Wrench2024-07-29 OXYGEN WRENCH
50628725097621 - Oxygen Wrench2024-07-29 OXYGEN WRENCH WITH SECURITY CHAIN
50628725000195 - Med-Rx2024-07-25 MICROBORE TUBING (I.D 0.023") W/ PINCH CLAMP, M/F LL.
50628725000218 - Med-Rx2024-07-25 MINIBORE TUBING (I.D 0.050") W/ SLIDE CLAMP, M/F LL.
50628725000232 - Med-Rx2024-07-25 MINIBORE TUBING (I.D 0.050") W/ SLIDE CLAMP, M/F L.L.
50628725000379 - Med-Rx2024-07-25 STANDARD BORE TUBING (I.D 0.095") W/ PINCH CLAMP, M/F LL

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