FDA.reportPublic FDA data

Santa Medical

Primary DI
06942820461590
Brand
Santa Medical
Company
Beijing Choice Electronic Technology Co., Ltd.
Model
SM-165
Device description
Finger Pulse Oximeter
Published
2017-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
true
Sterile
false
Single use
false

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
06942820461590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942820461590069428204615906942820461590

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942820462535BLUE JAYBJ2401052026-01-23
06942820462511VIEW O2180-50572025-12-23
06942820462528OxywatchDSI-DSFP-22025-12-23
00846841092527ChoiceMMedOxyWatch C292025-09-29
00846841092695ChoiceMMedMD300CN568R2025-09-24
00846841092596mibestIBH-0012025-07-23
00846841091599mibestMD300C572025-07-22
00846841092565ChoiceMMedMD300CI218R2025-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979934380042ConcordChangsha Brilliant Easesyn Technology Co.,Ltd.OCH2026-05-26
06979934380059ConcordChangsha Brilliant Easesyn Technology Co.,Ltd.OCH2026-05-26
08719481723408iProvènSevenground Trading B.V.OCH2026-03-09
06973912940525 simplicare IMDKOCH2025-12-03
00846841092527ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-09-29
06951740540360NOVAShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-08-07
00846841091599mibestBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00846841092701mibestBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00846841092947ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00850043916000ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850043916024ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850043916031ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00851697006543InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
00851697006659InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007513ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007698ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007704ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007728ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007780ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007803ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007810ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007827ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007919ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007964ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
06941900601314Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27
06941900601321Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27
06941900601338Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27
06941900601345Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27
06941900601352Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27
06941900601369Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27