FDA.reportPublic FDA data

NatureSpirit

Primary DI
00897037001229
Brand
NatureSpirit
Company
SIMPRO
Model
CMS-50D/CMS-50D1
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172141000Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.2018-04-04DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00897037001229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00897037001229008970370012298970370012290897037001229

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous 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 used bedside.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
188434448
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00897037001038NatureSpiritKD-59042017-02-24
00897037001014NatureSpiritBP-13072017-02-28
00810025922122Care MillCP-5002021-02-02
00810025922115Care MillCMS-50Q1 HIPPO2021-02-02
00810025923426Care MillCP-50FBLE2021-02-02
00810025923433Care MillC012021-02-02
00810025923440Care MillBaby Sound C2021-02-02
00810025924348Care MillCMS-50Q1 PIG2021-02-02
00810025924355Care MillCMS-50Q1 TIGER2021-02-02
00897037001113NatureSpiritCP-500E2020-04-21
00897037001687NatureSpiritCP-50BLE2020-04-21
00897037001076NatureSpiritCMS-50d2017-06-09
00897037001083NatureSpiritCMS-50dl2017-06-09
00897037001144NatureSpiritSonoline B2017-06-09
00897037001182NatureSpiritCMS-50E2017-06-29
00897037001212NatureSpiritCMS50DL2017-07-28
00897037001236NatureSpiritSHO-10022017-11-14
00897037001311NatureSpiritCMS-60D2017-07-17
00897037001472NatureSpiritCMS-50F2017-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01
00885403529644Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403529651Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403533191Acumen IQ PlusBecton, Dickinson And CompanyDXN2026-07-31
00885403533207VitaWaveBecton, Dickinson And CompanyDXN2026-07-31
00885403529637Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529668Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529774ClearSight JrBecton, Dickinson And CompanyDXN2026-07-29
00885403529781ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529798ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529811ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529828VitaWaveBecton, Dickinson And CompanyDXN2026-07-29
00194346614035equateWAL-MART STORES, INC.DXN2026-07-28
06953825911683SAKER UltraShenzhen Urion Technology Co., LtdDXN2026-07-27
06953825911645N/AShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911652ANOVATORShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911669SPASTACISEShenzhen Urion Technology Co., LtdDXN2026-07-24
06932825306057CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
00898939002758FORAFORA CARE INC.DXN2026-07-20
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13