GaleMed 4524-HD

GUDID 44710810100305

MANOMETER

GaleMed Xiamen Co., Ltd.

Airway pressure monitor, non-powered
Primary Device ID44710810100305
NIH Device Record Keyc61442ed-b47b-446d-a180-afbffd5bd7c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGaleMed
Version Model Number5409
Catalog Number4524-HD
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104710810100307 [Primary]
GS124710810100301 [Package]
Contains: 04710810100307
Package: Box [25 Units]
In Commercial Distribution
GS144710810100305 [Package]
Contains: 24710810100301
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)

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 Date2015-09-19

On-Brand Devices [GaleMed]

44710810114104Neonate Straight Connector 10F , 10M/7.6F
44710810101791Rescu-6 Manual Resuscitator, Infant w/ Mask #1
44710810101777Rescu-6 Manual Resuscitator, Child w/ Mask #3
44710810101753Rescu-6 Manual Resuscitator, Adult w/ Mask #5
44710810100305MANOMETER
44710810085206Child Wye Connector 15M w/Pressure Port
44710810085169Disposable Tee Valve
44710810084315Disposable Swivel Wye 22M
04710810084126CV-3 Single Limb Manifold
44710810083813Neonate Wye Connector 10M w/ Pressure Port
44710810082946Disposable Elbow 15M, 22/15mm, 6M
44710810082656Disposable Straight Connector 15M,7.6F Port&Cap,22/15mm
44710810082038Disposable Tube Clip 22mm
44710810080690Disposable Bi-Wye Connector 22M
44710810082915Disposable Adjustable PEEP Valve 5-20cmH2O

Trademark Results [GaleMed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GALEMED
GALEMED
78951610 3451433 Live/Registered
GALEMED CORPORATION
2006-08-14
GALEMED
GALEMED
77675314 3714487 Live/Registered
GALEMED CORPORATION
2009-02-21
GALEMED
GALEMED
75173619 not registered Dead/Abandoned
GALEMED CORPORATION
1996-09-30

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