FDA.reportPublic FDA data

Carex

Primary DI
00023601064189
Brand
Carex
Company
Drive Devilbiss Healthcare
Model
FGR41800 0000
Device description
Fingertip Pulse Oximeter
Published
2019-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
20023601064183PackageGS110In Commercial Distribution
30023601064180PackageGS1100In Commercial Distribution
00023601064189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002360106418320023601064183
3002360106418030023601064180
00023601064189000236010641890236010641890023601064189

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

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Primary DI, Brand, Company table
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06938395500321CONCORDShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-28
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
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
00850000967311CMI HealthCMI HEALTH INC.OCH2025-01-17
06941900601314Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27