FDA.reportPublic FDA data

AirLife™

Primary DI
30889483569522
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
001248U
Catalog number
001248U
Device description
AirLife™ Adult Venturi Style Tracheostomy Mask and U/Connect-It Adapter
Published
2025-03-28
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
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483569522PackageGS150In Commercial Distribution
10889483569528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948356952230889483569522
1088948356952810889483569528

GMDN Terms#

Term, Definition table
TermDefinition
Venturi oxygen face maskA flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
30889483573383AirLife™1209-5031209-5032025-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874950293Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874950750Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951016Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951344Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951351Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951368Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951375Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951399Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951405Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951412Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874952075Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874952082Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954826Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954833Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954840Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954857Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954864Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954871Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954888Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954895Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
00607411919077Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919091Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919121Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919084MedTronic CannulaSALTER LABSCAT2026-06-09
00607411919107Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
00607411919138Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
10197344155125MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
10197344158478HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-10-17
10197344158409HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158416HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26