FDA.reportPublic FDA data

LIVESAVER

Primary DI
24710810093184
Brand
LIVESAVER
Company
GaleMed Xiamen Co., Ltd.
Model
HD-5340
Catalog number
5340
Device description
MANUAL RESUSCITATOR, DURABLE, ADULT
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895589000MANUAL RESUSCITATORHudson Oxygen Therapy Sales Co.1990-03-30BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710810093180Direct MarkingGS10
44710810093188PackageGS112In Commercial Distribution
24710810093184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710810093180047108100931804710810093180
4471081009318844710810093188
2471081009318424710810093184

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, reusableA 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 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527333326
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26
06923980112621MindrayXMR00532026-05-26
06923980112638MindrayXMR00812026-05-26
06923980112690MindrayXMR01042026-05-26
06923980112799MindrayXMR00582026-05-26
06923980112805MindrayXMR00442026-05-26
06923980112829MindrayXMR00462026-05-26
06944904007236MindrayXMR00862026-05-26
16923980111843MindrayXMR02302026-05-26
06923980112522MindrayXMR00112026-05-25
06923980112539MindrayXMR00122026-05-25
06923980112553MindrayXMR00212026-05-25
06923980112560MindrayXMR00232026-05-25
06923980112645MindrayXMR00152026-05-25

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