811-BL 24V FOREIGN & DOMESTIC

GUDID 00816787020311

PARKS MEDICAL ELECTRONICS, INC.

Laser Doppler blood flowmeter
Primary Device ID00816787020311
NIH Device Record Key648992ca-d7c2-471f-8cc8-c52d7af5127f
Commercial Distribution StatusIn Commercial Distribution
Brand Name811-BL 24V FOREIGN & DOMESTIC
Version Model Number811-BL 24V 901C
Company DUNS009041773
Company NamePARKS MEDICAL ELECTRONICS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816787020311 [Primary]

FDA Product Code

DPWFLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [811-BL 24V FOREIGN & DOMESTIC]

00816787020328811-BL 24V NV
00816787020311811-BL 24V 901C
00816787020298811-BL 24V 800C

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