FDA.reportPublic FDA data

AirLife™

Primary DI
30889483603998
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
NIV041M
Catalog number
NIV041M
Device description
Non Invasive Ventilation (NIV) Non-Vented Full Face Mask without Anti-Asphyxiation Valve (Medium)
Published
2025-02-26
Public version status
New
Distribution status
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
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483603998PackageGS110In Commercial Distribution
10190752139374PreviousGS10
10889483603994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948360399830889483603998
1019075213937410190752139374
1088948360399410889483603994

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
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
30889483569522AirLife™001248U001248U2025-03-28
30889483570566AirLife™0018000018002025-03-28
30889483571914AirLife™0081780081782025-03-28
30889483570474AirLife™0016080016082025-03-27
30889483570559AirLife™0017970017972025-03-27
30889483570573AirLife™0018010018012025-03-27
30889483570597AirLife™0018030018032025-03-27
30889483570603AirLife™0018100018102025-03-27
30889483570658AirLife™0018220018222025-03-27
30889483570665AirLife™0018230018232025-03-27
30889483570672AirLife™0018240018242025-03-27
30889483570689AirLife™0018300018302025-03-27
30889483570863AirLife™0019510019512025-03-27
30889483570887AirLife™0019550019552025-03-27
30889483571679AirLife™0037600037602025-03-27
30889483571686AirLife™0037620037622025-03-27
30889483571693AirLife™0037640037642025-03-27
30889483572119AirLife™0P17750P17752025-03-27
30889483572126AirLife™0P17760P17762025-03-27
30889483572164AirLife™0Y37700Y37702025-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850057117370RESPOND VentilatorCORVENT MEDICAL, INCCBK2026-01-06
00850057117387Flow SensorCORVENT MEDICAL, INCCBK2026-01-06
00850057117394RESPOND Exhalation ManifoldCORVENT MEDICAL, INCCBK2026-01-06
00850057117400Exhalation ValveCORVENT MEDICAL, INCCBK2026-01-06
00850057117417RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/CORVENT MEDICAL, INCCBK2026-01-06
00850057117424HEPA FiltersCORVENT MEDICAL, INCCBK2026-01-06
00850057117448Green Oxygen Hose, 8ftCORVENT MEDICAL, INCCBK2026-01-06
00850057117455Oxygen Tubing with Connector, 7ftCORVENT MEDICAL, INCCBK2026-01-06
00850057117462Cart, IV Power StripCORVENT MEDICAL, INCCBK2026-01-06
00850057117479Cart, IV Power Strip MountCORVENT MEDICAL, INCCBK2026-01-06
00850057117486Patient Circuit Arm ClipCORVENT MEDICAL, INCCBK2026-01-06
00850070543033Emergency Ventilator Complete PackageVentis Medical Inc.CBK2025-12-31
00853678006733pNeuton Model A with 6ft Patient CircuitAIRON CORPORATIONCBK2025-12-19
20197344102652MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102669MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102676MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102683MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102690MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102706MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477507F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477514F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477521F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480453F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CBK2025-12-02
06903053046022VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBK2025-11-29
06903053046060VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBK2025-11-29
10190752190535LTVVYAIRE MEDICAL, INC.CBK2025-08-26
00850018761413Internal Battery PM Upgrade USB DriveVENTEC LIFE SYSTEMS, INC.CBK2025-08-06