FDA.reportPublic FDA data

BERRY®

Primary DI
06924054330040
Brand
BERRY®
Company
SHANGHAI BERRY ELECTRONIC TECH CO., LTD.
Model
BM1000E
Device description
Fingertip Pulse Oximeter
Published
2020-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

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
06924054330040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06924054330040069240543300406924054330040

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
529404533
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06924054300586BERRY®BM2000A2026-04-22
06924054300067 IGUANAMEDIGA100202021-01-21
06924054300005SANTAMEDICALSM-519BR-BL2020-04-17
06924054300456TeleRPMBM10002025-01-03
06924054300234BINACORBC35002023-10-10
06924054300029IntiMDINT-XM00012020-05-21
06924054300036AluratekABPM02F2020-06-10
06924054300043DANAVIDHW-1002020-11-03
06924054330163NatureSpirit®CP-50BLE2020-04-21
06924054330170NatureSpirit®CP-500E2020-04-21
06924054330033BERRY®BM1000D2020-04-02
06924054330149HigcabBM10002020-04-02
06924054330156Dark LightningBM10002020-04-02
06924054330132SANTAMEDICALBM10002020-03-27
06924054320003BERRY®贝瑞BM2000A2016-11-08
06924054330002BERRY®贝瑞BM1000A2016-11-08
06924054330026BERRY®贝瑞BM1000C2018-05-08
06924054330088BERRY®贝瑞BM10002018-05-08
06924054330095iHeart™BM1000B2018-11-22
06924054330118BERRY®BM1000B2018-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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00850043916024ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850043916031ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00851697006543InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
00851697006659InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
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00856964007728ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007780ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007803ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007810ZacurateEINSTEIN 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