Emergent Respiratory

GUDID 00850071887174

Breathing Circuit with Large S3 Mask

MDL Solutions Incorporated

Ventilator breathing circuit/mask
Primary Device ID00850071887174
NIH Device Record Key9f4c3cc9-684f-4051-b294-15c79d0d41be
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmergent Respiratory
Version Model Number1900-125
Company DUNS117921082
Company NameMDL Solutions Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850071887167 [Primary]
GS100850071887174 [Package]
Contains: 00850071887167
Package: Pack [5 Units]
In Commercial Distribution
GS100850071887181 [Package]
Contains: 00850071887167
Package: Pack [10 Units]
In Commercial Distribution
GS100850071887198 [Package]
Contains: 00850071887167
Package: Pack [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-14
Device Publish Date2025-04-05

On-Brand Devices [Emergent Respiratory]

00850071887242PortO2 Vent CPAP
00850071887174Breathing Circuit with Large S3 Mask
00850071887136Breathing Circuit with Small S3 Mask
00850071887013Breathing Circuit with Medium S3 Mask

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