FDA.reportPublic FDA data

Emergent Respiratory

Primary DI
00850071887280
Brand
Emergent Respiratory
Company
MDL Solutions Incorporated
Model
35100-100
Device description
Standalone Circuit
Published
2026-02-11
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
00850071887297PackageGS15In Commercial Distribution
00850071887303PackageGS110In Commercial Distribution
00850071887310PackageGS150In Commercial Distribution
00850071887280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071887297008500718872978500718872970850071887297
00850071887303008500718873038500718873030850071887303
00850071887310008500718873108500718873100850071887310
00850071887280008500718872808500718872800850071887280

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices 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 artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

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
00850071887297Emergent Respiratory35100-1002026-02-11
00850071887006Emergent Respiratory1900-1242025-04-05
00850071887129Emergent Respiratory1900-1232025-04-05
00850071887167Emergent Respiratory1900-1252025-04-05
00850071887013Emergent Respiratory1900-1242025-04-05
00850071887136Emergent Respiratory1900-1232025-04-05
00850071887174Emergent Respiratory1900-1252025-04-05
00850071887242Emergent Respiratory1900-0012025-04-05

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