FDA.reportPublic FDA data

Blender

Primary DI
10190752182011
Brand
Blender
Company
VYAIRE MEDICAL, INC.
Model
11798
Catalog number
11798
Device description
MICRO BLENDER,LOW FLOW,SIPAP
Published
2021-03-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031745000INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONSensor Medics Corp.2004-02-13BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190752182011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075218201110190752182011

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air breathing gas mixer, hospitalAn independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080456871
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752114791Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062020-01-15
10190752115200AirLife™0020030020032020-01-15
10190752141643Airlife™ Sterile Water for Inhalation, USP, 500 ml0026200026202021-04-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814747025017Arie Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025024Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025031Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025048Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025055Ascend Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025062Ascend Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025079Ascend Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025086Ascend Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025093Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025109Arie Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025116Arie Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025123Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025130Ascend Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025147Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025154Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025161Ascend Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025178IQ 2 Nasal MaskSLEEPNET, CORP.BZD2026-10-23
00814747025185Phantom 2 Nasal Vented MaskSLEEPNET, CORP.BZD2026-10-23
00814747025192MiniMe 2 Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-10-23
00814747025208MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025215MiniMe 2 Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025222MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025314Novaplus Full Face Vented Mask, Extra LargeSLEEPNET, CORP.BZD2026-10-23
00814747025321Novaplus Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025338Novaplus Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025345Novaplus Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025352Novaplus Hospital Nasal Non Vented Mask, m/lSLEEPNET, CORP.BZD2026-10-23
00814747025369Novaplus Hospital Nasal Non Vented Mask, s/mSLEEPNET, CORP.BZD2026-10-23
00814747025376Novaplus Hospital Nasal Vented Mask, m/lSLEEPNET, CORP.BZD2026-10-23
00814747025383Novaplus Hospital Nasal Vented Mask, s/mSLEEPNET, CORP.BZD2026-10-23