3100A HFOV

Primary DI
50190752155426
Brand
3100A HFOV
Company
VYAIRE MEDICAL, INC.
Model
771374
Catalog number
771374
Device description
Flexible Patient Circuit, 3100A MR730 in Heated Environment (Box of 4)
Published
2021-05-05
Public version status
Update
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
LSZVENTILATOR, HIGH FREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSZVentilator, High FrequencyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890057000MODEL 3100 FREQUENCY OSCILLATORY VENTILATORZOLL Medical Corporation1991-03-29LSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752155426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215542650190752155426

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. 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 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
080456871
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10190752114869AirLife™0024380024382020-01-15
10190752114876AirLife™0024390024392020-01-15
10190752114883AirLife™0024400024402021-04-02
10190752114890AirLife™0024420024422020-01-15
10190752114906AirLife™0024430024432020-01-15
10190752114913AirLife™0024440024442020-01-15
10190752114920AirLife™0024450024452020-01-15
10190752114937AirLife™0024460024462020-01-15
10190752114944AirLife™0024500024502020-01-15
10190752114968AirLife™0024580024582020-01-15
10190752114975AirLife™0025010025012020-01-15
10190752114982AirLife™0025020025022020-01-15
10190752114999AirLife™0025300025302020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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201907522010613100A HFOVVYAIRE MEDICAL, INC.LSZ2025-07-16
101907522010193100 HFOVVYAIRE MEDICAL, INC.LSZ2024-11-05
101907522007463100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907522007603100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907522015763100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907521488403100A/B HFOVVYAIRE MEDICAL, INC.LSZ2021-11-08
501907521599123100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-16
501907521551053100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551123100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551293100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551363100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551433100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521554883100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521589843100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521590043100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521597453100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
101907521588013100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
101907521588183100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
101907521588253100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521551503100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521552593100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521552663100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554333100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554573100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554643100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554713100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554953100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521575673100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521589153100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05