FDA.reportPublic FDA data

iHealth

Primary DI
00855111003279
Brand
iHealth
Company
iHealth Labs Inc.
Model
PO3
Published
2023-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
10855111003276PackageGS124In Commercial Distribution
20855111003273PackageGS196In Commercial Distribution
00855111003279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085511100327610855111003276
2085511100327320855111003273
00855111003279008551110032798551110032790855111003279

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
054953337
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856362005814iHealthPT12021-04-01
00850044118656iHealthICF-3000P2026-05-15
00850078377180iHealthICR-30002026-05-15
00850078377272iHealthCSW-ANSCR2026-05-15
00850044118427iHealthICF-30002024-05-25
00850044118434iHealthICF-30002024-05-24
00850044118458iHealthICF-30002024-05-24
00856362005890iHealthICO-30002022-09-16
00856362005906iHealthICO-30002022-09-16
00850044118205iHealthEGS-20032023-08-24
00850044118236iHealthBG5SKIT2024-05-28
00850044118250iHealthEGS-20032023-08-30
00850044118267iHealthEGS-20032023-08-30
00856362005005iHealthKN-550BT2022-10-01
00856362005050iHealthBPM12023-08-14
00856362005104iHealthBP3L2022-09-30
00856362005142iHealthBP5S2025-03-03
00856362005159iHealthBG5SKIT2025-12-19
00856362005197iHealthEGS-20032019-01-09
00856362005821iHealthPT3SBT2021-04-14

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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
00850043916000ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
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00851697006659InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
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00856964007810ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007827ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
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00856964007964ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850000967311CMI HealthCMI HEALTH INC.OCH2025-01-17
06941900601314Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27