FDA.report

AirLife™

Primary DI
30889483569447
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
001240
Catalog number
001240
Device description
AirLife™ Adult Venturi Style Mask Vinyl, Under-the-Chin Style
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

Related Records

Contact Domains

Product Codes

CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483569447PackageGS150In Commercial Distribution
10190752116443PreviousGS10
10889483569443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948356944730889483569447
1019075211644310190752116443
1088948356944310889483569443

GMDN Terms

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.

Sterilization Methods

Method

Contacts

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 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

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20885632467452HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
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20889483223014Montgomery DMESUNMED, LLCCAT2025-12-30
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20197344161208MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161215MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161222MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161239MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
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