ADVANCED DOPPLER

GUDID B510TD50001

ADVANCED INSTRUMENTATIONS, INC.

Foetal Doppler system
Primary Device IDB510TD50001
NIH Device Record Key9e86b723-f3ac-48d9-b9c0-b2bc33e7ab87
Commercial Distribution Discontinuation2028-04-15
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVANCED DOPPLER
Version Model NumberTD-5000
Company DUNS608736880
Company NameADVANCED INSTRUMENTATIONS, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB510TD50001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNGMonitor, Ultrasonic, Fetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-27
Device Publish Date2020-04-17

Devices Manufactured by ADVANCED INSTRUMENTATIONS, INC.

B510SL500FL0 - ADVANCED SURGICAL LIGHT FLOOR STANDING2021-01-08
B510SL500FLLED0 - ADVANCED SURGICAL LIGHT FLOOR STANDING LED2021-01-08
B510SL500LED0 - ADVANCED SURGICAL LIGHT CEILING MOUNTED LED2021-01-08
B510SL7007000 - ADVANCED SURGICAL LIGHT CEILING MOUNTED2021-01-08
B510CMS1000FM1 - ADVANCED CENTRAL MONITORING STATION2020-04-27
B510CMS20001 - ADVANCED CENTRAL MONITORING STATION2020-04-27
B510DUS30001 - ADVANCED ULTRASOUND2020-04-27
B510DUS5000A1 - ADVANCED ULTRASOUND2020-04-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.