FDA.reportPublic FDA data

AirLife™

Primary DI
30889483585881
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
5424BDG1
Catalog number
5424BDG1
Device description
AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
Published
2025-02-18
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
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911465000INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APLVital Signs, Inc.1991-10-18BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483585881PackageGS120In Commercial Distribution
10190752145962PreviousGS10
10889483585887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948358588130889483585881
1019075214596210190752145962
1088948358588710889483585887

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. 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
00848530106461CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106478CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106485CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106492CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106508CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106515CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-17
00848530106355CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106362Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106379CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106386CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106393CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106409Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
10889483586358Vital Signs™AIRLIFEBZD2025-02-18
00848530081638CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530085230CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090661CPAP MaskSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090678CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090685CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090692CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090708CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090715CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090722CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090739CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090746CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097103CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097110CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097127CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097134CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097141CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097158CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29