FDA.reportPublic FDA data

AirLife™

Primary DI
30889483599550
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
FM2625
Catalog number
FM2625
Device description
AirLife™ Adult Cushion Nasal Cannula With Foam Ear Covers and 25 foot (7.6 m) Crush-Resistant Oxygen Tubing
Published
2025-02-19
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
NFBConserver, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFBConserver, OxygenAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023673000AIRLIFE DEMAND NASAL CANNULAAllegiance Healthcare Corp.2003-05-02NFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483599550PackageGS125In Commercial Distribution
10190752117563PreviousGS10
10889483599556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948359955030889483599550
1019075211756310190752117563
1088948359955610889483599556

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
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
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
00841447198093Invacare® Element™ Pneumatic ConserverINVACARE CORPORATIONNFB2026-09-22
10889483599556AirLife™AIRLIFENFB2025-02-19
10889483605783AirLife™AIRLIFENFB2025-02-19
30889483605787AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
10889483605806AirLife™AIRLIFENFB2025-02-18
30889483605800AirLife™Sunmed Group Holdings, LLCNFB2025-02-18
00850027043746Precision MedicalPrecision Medical, Inc.NFB2024-12-12
00822383024875SmartDose EvolutionINOVO, INC.NFB2024-11-07
50822383024870SmartDose EvolutionINOVO, INC.NFB2024-11-07
00850027997001DynarisIncoba LLCNFB2023-12-14
00822383504322DriveINOVO, INC.NFB2023-10-16
00822383018553EVOLUTION INOVO, INC.NFB2023-05-25
00822383515557Evolution™INOVO, INC.NFB2023-05-25
50822383018558EVOLUTION INOVO, INC.NFB2023-05-25
50822383515552Evolution™INOVO, INC.NFB2023-05-25
00822383018522EVOLUTION INOVO, INC.NFB2023-04-28
00822383018515DriveINOVO, INC.NFB2022-09-21
00814470020297BONSAI INOVO, INC.NFB2021-09-20
10080196193080MedlineMEDLINE INDUSTRIES, INC.NFB2021-03-31
10080196752287MedlineMEDLINE INDUSTRIES, INC.NFB2021-03-31
10190752115057Airlife™AIRLIFENFB2021-03-09
50190752115055Airlife™VYAIRE MEDICAL, INC.NFB2021-03-09
00855887006962Easy Pulse 5 Oxygen Conserving RegulatorPrecision Medical, Inc.NFB2021-03-05
00855887006627Easy Pulse 5 Oxygen Conserving RegulatorPrecision Medical, Inc.NFB2021-02-25
00854485007197ARES Nasal CannulaWatermark Medical, Inc.NFB2021-02-22
00822383274485driveDrive Devilbiss HealthcareNFB2020-07-01
00822383283814driveDrive Devilbiss HealthcareNFB2020-07-01
00822383284101driveDrive Devilbiss HealthcareNFB2020-07-01
00822383296401driveDrive Devilbiss HealthcareNFB2020-07-01
00885304002970DeVilbissDEVILBISS HEALTHCARE LLCNFB2020-04-03