LIVESAVER 5340

GUDID 24710810093184

MANUAL RESUSCITATOR, DURABLE, ADULT

GaleMed Xiamen Co., Ltd.

Pulmonary resuscitator, manual, reusable
Primary Device ID24710810093184
NIH Device Record Key88766cc7-d5ab-43c4-8106-db9a4f24bc8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIVESAVER
Version Model NumberHD-5340
Catalog Number5340
Company DUNS527333326
Company NameGaleMed Xiamen Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104710810093180 [Direct Marking]
GS124710810093184 [Primary]
GS144710810093188 [Package]
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-28

Devices Manufactured by GaleMed Xiamen Co., Ltd.

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06923980108686 - Mindray2024-07-29 Disposable respiratory circuit, Single Limb
46923980108691 - Mindray2024-07-29 Reusable Breathing Circuit, Single Limb
46923980111172 - Mindray2024-07-29 Disposable respiratory circuit, Single Limb
06923980104824 - N/A2024-06-04 Softip-1 Nasal Cannula, Adult
46923980108844 - N/A2024-06-04 Silicone J-Circuit, Adult
06923980104435 - N/A2023-12-20 Disposable Anesthesia Circuit, Coaxial Circuit, Adult, 180cm

Trademark Results [LIVESAVER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIVESAVER
LIVESAVER
85342695 not registered Dead/Abandoned
Life Paint Company, Inc.
2011-06-09

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