2.15MHZ OB PROBE

GUDID 00816787023329

PARKS MEDICAL ELECTRONICS, INC.

Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe
Primary Device ID00816787023329
NIH Device Record Key1b28c67a-42f1-4b1f-8023-b4cd8208e8c7
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.15MHZ OB PROBE
Version Model Number832-6215-11
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 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

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
Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com
Phone+1(800)547-6427
Emailtwelker@parksmed.com
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
GS100816787023329 [Primary]

FDA Product Code

HGLTRANSDUCER, ULTRASONIC, OBSTETRIC

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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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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