DOPPLER MODEL 810-A

GUDID 00816787020199

PARKS MEDICAL ELECTRONICS, INC.

Laser Doppler blood flowmeter
Primary Device ID00816787020199
NIH Device Record Key3fa86f55-2170-4a74-aa37-87b0d68a2574
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOPPLER MODEL 810-A
Version Model Number810-A(F)
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
GS100816787020199 [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

Devices Manufactured by PARKS MEDICAL ELECTRONICS, INC.

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00816787024333 - 8.3MHz Pencil Probe 7 Foot ODU connector2022-05-23
00816787024340 - 8.7MHz Pencil Probe 7 Foot ODU connector2022-05-23
00816787024357 - 9.1MHz Pencil Probe 7 Foot ODU connector2022-05-23
00816787024364 - 9.4MHz Pencil Probe 7 Foot ODU connector2022-05-23
00816787024371 - 9.7MHz Pencil Probe 7 Foot ODU connector2022-05-23
00816787024302 - 8.1 MHz Pencil Probe 7FT Contoured2021-05-24

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