Face mask - Pediatric R-2755SM

GUDID 50628725095542

PEDIATRIC THREE-IN-ONE MASK with 7’ Saflo Tube w/multi-fit connector

Canadian Hospital Specialties Limited

Rebreathing oxygen face mask
Primary Device ID50628725095542
NIH Device Record Key7cfc922c-211b-4be6-9ff2-59cbb93867e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameFace mask - Pediatric
Version Model NumberR-2755SM
Catalog NumberR-2755SM
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
GS100628725095547 [Primary]
GS150628725095542 [Package]
Contains: 00628725095547
Package: Corrugate Case [50 Units]
In Commercial Distribution

FDA Product Code

KGBMask, Oxygen, Non-Rebreathing

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

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