FDA.reportPublic FDA data

Equate

Primary DI
00681131235266
Brand
Equate
Company
WAL-MART STORES, INC.
Model
MD300CN310
Device description
Fingertip Pulse Oximeter
Published
2017-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
10681131235263PackageGS12In Commercial Distribution
20681131235260PackageGS16In Commercial Distribution
00681131235266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068113123526310681131235263
2068113123526020681131235260
00681131235266006811312352666811312352660681131235266

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.

Regulatory Flags#

DUNS number
051957769
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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