FDA.reportPublic FDA data

AirLife™

Primary DI
30889483580527
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
30303EU
Catalog number
30303EU
Device description
AirLife™ Bacterial/Viral Filter
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
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483580527PackageGS150In Commercial Distribution
10190752148772PreviousGS10
10889483580523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948358052730889483580527
1019075214877210190752148772
1088948358052310889483580523

GMDN Terms#

Term, Definition table
TermDefinition
Microbial medical gas filter, single-useA screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

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
true
Manufacturing date on label
true
Expiration date on label
false
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
06950743609432Breathing Circuit Bacterial/Viral FilterShaoxing Haitech Medical Products Co., LtdCAH2026-05-23
04716770701127HME W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770701158Angled HME with luer lock portBESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770702230Bacterial Filter (Dead space 32ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703067HMEF (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
30889483228108Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228115Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228122Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228139Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228146Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228153Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228160Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228177Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228207Cardinal HealthSUNMED, LLCCAH2025-12-31
20889483229740BlockAide™SUNMED, LLCCAH2025-12-31
20889483231675Vital Signs™SUNMED, LLCCAH2025-12-31
20889483233198Vital Signs™SUNMED, LLCCAH2025-12-31
20889483233891Vital Signs™SUNMED, LLCCAH2025-12-31
20889483231750PRO-NOX™SUNMED, LLCCAH2025-12-30
20889483232306Vital Signs™SUNMED, LLCCAH2025-12-30
20889483232849Vital Signs™SUNMED, LLCCAH2025-12-30
20889483233389Vital Signs™SUNMED, LLCCAH2025-12-30
20889483234195Vital Signs™SUNMED, LLCCAH2025-12-30
20889483221188Vital Signs™SUNMED, LLCCAH2025-12-23
20889483222543Vital Signs™SUNMED, LLCCAH2025-12-23
20889483226787Vital Signs™SUNMED, LLCCAH2025-12-23
20889483230487Vital Signs™SUNMED, LLCCAH2025-12-23
20889483231163Vital Signs™SUNMED, LLCCAH2025-12-23