FDA.reportPublic FDA data

AirLife

Primary DI
50885403415768
Brand
AirLife
Company
Carefusion Corporation
Model
NIV044S
Catalog number
NIV044S
Device description
AirLife™ NIV NON-VENTED NASAL MASK - SMALL
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403415768PackageGS110Not in Commercial Distribution
10885403415760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540341576850885403415768
1088540341576010885403415760

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
830432451
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752101876TiaraTMS-2820912016-09-13
10190752101883TiaraTMS-2821912016-09-13
10190752101890TiaraTMS-2830912016-09-13
10190752101913TiaraTMS-2831912016-09-13
10190752101920TiaraTMS-2840912016-09-13
10190752101944TiaraTMS-2841912016-09-13
10190752101951TiaraTMS-2850912016-09-13
10190752101975TiaraTMS-2851912016-09-13
10190752102033TiaraTMS-12032016-09-13
10190752102040TiaraTMS-1203782016-09-13
10190752102057TiaraTMS-12532016-09-13
10190752102064TiaraTMS-1253782016-09-13
10190752102071TiaraTMS-14032016-09-13
10190752102088TiaraTMS-1403782016-09-13
10190752102095TiaraTMS-25202016-09-13
10190752102101TiaraTMS-25402016-09-13
10190752102118TiaraTMS-2540782016-09-13
10190752102125TiaraTMS-28202016-09-13
10190752102132TiaraTMS-28302016-09-13
10190752102149TiaraTMS-28402016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012464699Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
04719893347258WellellWellell Inc.BZD2026-03-17
04719893347265WellellWellell Inc.BZD2026-03-17
04719893347272WellellWellell Inc.BZD2026-03-17
24710810084946N/AGALEMED CORPORATIONBZD2026-03-05
44710810089747N/AGALEMED CORPORATIONBZD2026-03-05
44710810115620N/AGALEMED CORPORATIONBZD2026-03-05
44710810115637N/AGALEMED CORPORATIONBZD2026-03-05
44710810109636N/AGALEMED CORPORATIONBZD2026-03-05
44710810109643N/AGALEMED CORPORATIONBZD2026-03-05
44710810109650N/AGALEMED CORPORATIONBZD2026-03-05
44710810119666N/AGALEMED CORPORATIONBZD2026-03-05
44710810110175N/AGALEMED CORPORATIONBZD2026-03-05
44710810112452N/AGALEMED CORPORATIONBZD2026-03-05
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00814747024683Arie Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-03-04
00814747024690Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
00814747024706Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-03-04
00814747024713Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-03-04
00814747024720Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-03-04
00814747024737Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
00814747024744Arie Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-03-04
10848530108356Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108363Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108370Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108387Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
16948538340162Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340179Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340186Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340193Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02