FDA.reportPublic FDA data

3100A HFOV

Primary DI
50190752155495
Brand
3100A HFOV
Company
VYAIRE MEDICAL, INC.
Model
773997
Catalog number
773997
Device description
Flexible Patient Circuit, 3100A, MR850 in Non-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
50190752155495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215549550190752155495

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
10190752129993LTV11581-G11581-G2021-02-22
10190752153158VELA11571115712021-03-29
10190752114814AirLife™0024320024322020-01-15
10190752114821AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) 0024330024332020-01-15
10190752114838AirLife™0024340024342020-01-15
10190752114845AirLife™0024350024352020-01-15
10190752114852AirLife™0024370024372020-01-15
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
101907521553123100A HFOVVYAIRE MEDICAL, INC.LSZ2025-07-16
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
501907521554263100A 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
501907521575673100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521589153100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05