Dr. Talbot's

GUDID 20370797149225

TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC

Pulse oximeter, battery-powered
Primary Device ID20370797149225
NIH Device Record Keyb1d00057-819f-44d3-b6c5-5b8c13dcb9ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameDr. Talbot's
Version Model Number14922
Company DUNS078855555
Company NameTALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100370797149221 [Primary]
GS120370797149225 [Package]
Contains: 00370797149221
Package: [6 Units]
In Commercial Distribution
GS130370797149222 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Product Code

OCHOximeter, Infrared, Sporting, Aviation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-02
Device Publish Date2020-10-23