ADVANCED POCKET DOPPLER

GUDID B510PD1000PRO1

ADVANCED INSTRUMENTATIONS, INC.

Foetal Doppler system
Primary Device IDB510PD1000PRO1
NIH Device Record Key92b19d5d-85ba-4724-9aa1-6d8737303ba5
Commercial Distribution Discontinuation2028-04-15
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVANCED POCKET DOPPLER
Version Model NumberPD-1000 PRO
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
HIBCCB510PD1000PRO1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEPMonitor, Blood-Flow, Ultrasonic

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

On-Brand Devices [ADVANCED POCKET DOPPLER]

B510PD100PRO1PD-100 PRO
B510PD1000PRO1PD-1000 PRO

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