FDA.report

AirLife™

Primary DI
30889483570146
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
001363
Catalog number
001363
Device description
AirLife™ Adult Venturi Style Mask Vinyl, Under-the-Chin Style Adult Mask, 6 inch (15 cm) Flextube, Six Diluter Jets, Nebulizer Hood, 7 feet (2.1 m) Oxygen Tubing and U/Connect-It Adapter
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
30889483570146PackageGS150In Commercial Distribution
10190752116689PreviousGS10
10889483570142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948357014630889483570146
1019075211668910190752116689
1088948357014210889483570142

GMDN Terms

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

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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00850077887079AERIS Airway - Female Luer KitAirway Innovations, Inc.CAT2026-01-08
20889483223014Montgomery DMESUNMED, LLCCAT2025-12-30
20197344162694CARINGMEDLINE INDUSTRIES, INC.CAT2025-11-27
20197344158406HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
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20197344158451HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
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20197344158468HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
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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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