FDA.reportPublic FDA data

Emergent Respiratory

Primary DI
00850071887167
Brand
Emergent Respiratory
Company
MDL Solutions Incorporated
Model
1900-125
Device description
Breathing Circuit with Large S3 Mask
Published
2025-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021520000EMT-CPAPEmergency Medical Techology2002-07-15BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071887174PackageGS15In Commercial Distribution
00850071887181PackageGS110In Commercial Distribution
00850071887198PackageGS150In Commercial Distribution
00850071887167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071887174008500718871748500718871740850071887174
00850071887181008500718871818500718871810850071887181
00850071887198008500718871988500718871980850071887198
00850071887167008500718871678500718871670850071887167

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit/maskAn assembly of devices that includes a breathing circuit and a respiratory mask designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient during noninvasive ventilation. It includes breathing tubes, a Y-piece connector, and typically provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
6125427979help@emergentcpap.com

Regulatory Flags#

DUNS number
117921082
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850071887280Emergent Respiratory35100-1002026-02-11
00850071887297Emergent Respiratory35100-1002026-02-11
00850071887006Emergent Respiratory1900-1242025-04-05
00850071887129Emergent Respiratory1900-1232025-04-05
00850071887013Emergent Respiratory1900-1242025-04-05
00850071887136Emergent Respiratory1900-1232025-04-05
00850071887174Emergent Respiratory1900-1252025-04-05
00850071887242Emergent Respiratory1900-0012025-04-05

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Primary DI, Brand, Company table
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