FDA.reportPublic FDA data

Dr. Talbot's

Primary DI
00370797149207
Brand
Dr. Talbot's
Company
TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC
Model
14920
Published
2020-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OCHOximeter, Infrared, Sporting, Aviation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCHOximeter, Infrared, Sporting, AviationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20370797149201PackageGS16In Commercial Distribution
30370797149208PackageGS14In Commercial Distribution
00370797149207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2037079714920120370797149201
3037079714920830370797149208
00370797149207003707971492073707971492070370797149207

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Regulatory Flags#

DUNS number
078855555
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370797780998Dr Talbot's780992024-08-02
30370797780999Dr Talbot's780992024-08-02
00370797011016Dr. Talbot's11012020-10-23
00370797011009Dr. Talbot's11002020-10-23
00370797149214Dr. Talbot's149212020-10-23
00370797149221Dr. Talbot's149222020-10-23
20370797011010Dr. Talbot's11012020-10-23
20370797149201Dr. Talbot's149202020-10-23
20370797149218Dr. Talbot's149212020-10-23
20370797149225Dr. Talbot's149222020-10-23
00370797801006Dr. Talbot's801002020-07-15
00370797801013Dr. Talbot's801012020-07-15
20370797801000Dr. Talbot's801002020-07-15
20370797801017Dr. Talbot's801012020-07-15
00370797149009Dr. Talbot's149002020-06-18
00370797150005Dr. Talbot's150002020-06-18

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