Emergent Respiratory

GUDID 00850071887297

Standalone Circuit

MDL Solutions Incorporated

Ventilator breathing circuit, single-use
Primary Device ID00850071887297
NIH Device Record Key2b9abd70-d54a-4997-b3ef-54dab1d99f15
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmergent Respiratory
Version Model Number35100-100
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
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com
Phone6125427979
Emailhelp@emergentcpap.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850071887280 [Primary]
GS100850071887297 [Package]
Contains: 00850071887280
Package: Pack [5 Units]
In Commercial Distribution
GS100850071887303 [Package]
Contains: 00850071887280
Package: Pack [10 Units]
In Commercial Distribution
GS100850071887310 [Package]
Contains: 00850071887280
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 Date2026-02-19
Device Publish Date2026-02-11

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
00850071887297Standalone Circuit

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.