Adult Three-In-One Mask with Multi-fit Connector on 7' Saflo Tube R-2255SM

GUDID 50628725099557

MASK ADULT 3 IN 1 OXYGEN WITH 7' SAFLO OXYGEN TUBING MULTIFIT CONNECTOR

Respan Products Inc

Rebreathing oxygen face mask
Primary Device ID50628725099557
NIH Device Record Key325ae13f-0c71-455d-a949-0e59b5ffbb90
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Three-In-One Mask with Multi-fit Connector on 7' Saflo Tube
Version Model NumberR-2255SM
Catalog NumberR-2255SM
Company DUNS243175213
Company NameRespan Products Inc
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
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
GS100628725099552 [Primary]
GS150628725099557 [Package]
Contains: 00628725099552
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 Date2023-07-06
Device Publish Date2023-06-28