FDA.report

Well at Walgreens

Primary DI
00846841032080
Brand
Well at Walgreens
Company
Beijing Choice Electronic Technology Co., Ltd.
Model
OxyWatch C20
Device description
Fingertip Pulse Oximeter
Published
2016-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OCHOximeter, Infrared, Sporting, Aviation

Product Code Classifications

CodeDeviceSpecialtyClass
OCHOximeter, Infrared, Sporting, AviationCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10846841032087PackageGS148In Commercial Distribution
00846841032080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084684103208710846841032087
00846841032080008468410320808468410320800846841032080

GMDN Terms

TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the 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 applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods

Method

Regulatory Flags

DUNS number
526882823
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00846841092596mibestIBH-0012025-07-23
00846841091599mibestMD300C572025-07-22
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00846841092701mibestMD300C562025-07-22
00846841092947ChoiceMMedOxyWatch C2052025-07-22
00846841092954ChoiceMMedMD300CN550R2025-07-22
06942820462504Choicemmed MD300W6282025-07-22
00846841092589mibestNA-0022025-07-18
06942820462368ChoicemmedMD300CI218R2025-04-27
06942820462375ChoicemmedMD300CI216R2025-04-27
06942820462399ChoicemmedMD300C2282025-04-27
06942820462405ChoicemmedMD300C22025-04-27
06942820462412ChoicemmedMD300C212025-04-27
06942820462429ChoicemmedMD300C222025-04-27
06942820462436ChoicemmedMD300C232025-04-27

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08719481723408iProvènSevenground Trading B.V.OCH2026-03-09
06973912940525 simplicare IMDKOCH2025-12-03
00846841092527ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-09-29
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