FDA.reportPublic FDA data

Santamedical

Primary DI
10858759005596
Brand
Santamedical
Company
GURIN PRODUCTS LLC
Model
SM-150G
Device description
Santamedical Sports/Aviation Pulse Oximeter
Published
2018-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10858759005596PackageGS1200In Commercial Distribution
00858759005599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085875900559610858759005596
00858759005599008587590055998587590055990858759005599

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
022069446
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
false
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
00858759005421MEDVICEMV-9502024-10-17
10858759005428MEDVICEMV-9502024-10-17
00858759005490SantamedicalSM-1100S2018-06-29
00858759005506SantamedicalSM-1100BL2018-06-29
00858759005582SantamedicalSM-150B2018-06-29
00858759005599SantamedicalSM-150G2018-06-29
00858759005605SantamedicalSM-150Y2018-06-29
00858759005391SantamedicalSM-1652018-02-08
00858759005483SantamedicalSM-1102018-06-29
00858759005513SantamedicalSM-1100P2018-06-29
10858759005497SantamedicalSM-1100S2018-06-29
10858759005503SantamedicalSM-1100BL2018-06-29
10858759005589SantamedicalSM-150B2018-06-29
10858759005602SantamedicalSM-150Y2018-06-29

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Primary DI, Brand, Company table
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06938395500314AccuMedShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-27
06938395500284AccuMedShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-15
08719481723408iProvènSevenground Trading B.V.OCH2026-03-09
06973912940525 simplicare IMDKOCH2025-12-03
06951740540377THERMOBIOShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-10-18
00846841092527ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-09-29
06951740540360NOVAShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-08-07
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00846841092701mibestBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00846841092947ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
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00851697006659InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
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00856964007728ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
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