FDA.reportPublic FDA data

Care Mill

Primary DI
00810025922122
Brand
Care Mill
Company
SIMPRO
Model
CP-500
Device description
Digital Fingertip Oximeter
Published
2021-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
PGJOximeter, Wellness

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGJOximeter, WellnessCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810025922122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810025922122008100259221228100259221220810025922122

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
188434448
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00897037001038NatureSpiritKD-59042017-02-24
00897037001229NatureSpiritCMS-50D/CMS-50D12019-03-29
00897037001014NatureSpiritBP-13072017-02-28
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
00850022853067ProSomnus HWO2 DevicePROSOMNUS SLEEP TECHNOLOGIESPGJ2026-04-24
06938395500291HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-04-22
06938395500307HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-04-22
00786585793505SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601921MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601938MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601945MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601952MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392211213MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392211244SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392218793MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392218724SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-27
06938395500253HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-03-13
00050428168721CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00050428168738CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00846841092695ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-09-24
B635BIOKIT0100Biokit O2BIOTRICITY INCPGJ2025-09-24
00845717010139Veridian HealthcareVERIDIAN HEALTHCARE LLCPGJ2025-09-09
30845717010130Veridian HealthcareVERIDIAN HEALTHCARE LLCPGJ2025-09-09
00845717011945R.P.M. PROVERIDIAN HEALTHCARE LLCPGJ2025-09-08
00845717012164TrackstarVERIDIAN HEALTHCARE LLCPGJ2025-09-08
00846841092565ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-07-22
00846841092954ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-07-22
06942820462498ChoicemmedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-04-27
00850000967014CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967038CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967052CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967311CMI HealthCMI HEALTH INC.PGJ2025-01-17
06941900601406Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27
06941900603394Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27