FDA.reportPublic FDA data

Zacurate

Primary DI
00856964007094
Brand
Zacurate
Company
EINSTEIN ASSOCIATES LLC
Model
500D Black
Catalog number
M430N-DLBK-JPZA
Device description
Fingertip Pulse Oximeter
Published
2017-10-30
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
00856964007094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856964007094008569640070948569640070940856964007094

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

Contacts#

Phone, Email table
PhoneEmail
8329398290cs@beyondmedshop.com

Regulatory Flags#

DUNS number
080641505
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043916000Zacurate500E PurpleM430N-DLVO-CMZA-3M2025-01-28
00850043916024Zacurate500E-BM430N-BLWH-CMZA2025-01-28
00850043916031Zacurate500B-BM430N-BBBL-LHZA2025-01-28
00850043916178VaunnvB100A-MM420N-MGWH-MLVM2025-01-28
00850043916185VaunnvB100A-LM420N-LGWH-MLVM2025-01-28
00851697006543InnovoiP900APM430N-PEWH-CMIM-42025-01-28
00851697006659InnovoiP900BP-BM430N-CBWH-CMIM2025-01-28
00856964007513Zacurate500CLM430N-ABCL-CMZA2025-01-28
00856964007698Zacurate500DL BlackM430N-AABK-CMZA2025-01-28
00856964007704Zacurate500DL PurpleM430N-AAVO-CMZA2025-01-28
00856964007728Zacurate500C BlackM430N-DCBK-CMZA2025-01-28
00856964007780Zacurate500E BlackM430N-DLBK-CMZA2025-01-28
00856964007803Zacurate500DL PinkM430N-AAPK-JPZA-M22025-01-28
00856964007810Zacurate500E PinkM430N-DLPK-CMZA-AX2025-01-28
00856964007827Zacurate500E WhiteM430N-DLWH-CMZA-42025-01-28
00856964007919Zacurate500DL-M BlackM430N-MABK-CMZA2025-01-28
00856964007964Zacurate500BLM430N-MBBL-CMZA2025-01-28
00856964007339ZacurateM491N-2WVB-EGZAM491N-2WVB-EGZA2018-06-29
00856964007322ZacurateM490N-CBAA-EGZAM490N-CBAA-EGZA2018-06-29
00856964007001Zacurate430PM430N-PDWH-CMZA2017-06-13

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
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