FDA.reportPublic FDA data

AirLife™

Primary DI
30889483586512
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
5524BDH
Catalog number
5524BDH
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
30889483586512PackageGS120In Commercial Distribution
10190752145733PreviousGS10
10889483586518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948358651230889483586512
1019075214573310190752145733
1088948358651810889483586518

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
false
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

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Primary DI, Brand, Company table
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10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
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