GUDID 00840682115599

GE Vingmed Ultrasound AS

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682115599
NIH Device Record Keybebdf4d5-79c4-436d-8155-92ee0ea692eb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberP2D-RS
Company DUNS518870571
Company NameGE Vingmed Ultrasound AS
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682115599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-07-15

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