FDA.reportPublic FDA data

OxyKnight

Primary DI
00850000967403
Brand
OxyKnight
Company
CMI HEALTH INC.
Model
CF-100B
Device description
OxyKnight Fingertip Oximeter CF-100B
Published
2024-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211632000Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)Shenzhen Narig Bio-Medical Technology Co., Ltd.2022-01-14DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000967403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000967403008500009674038500009674030850000967403

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-985-1125info@cmihealth.com

Regulatory Flags#

DUNS number
079963616
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000967328SpiroLoopPF-A92026-03-06
00850000967625SpiroLink 2 ProPF-A3P2026-03-06
00850000967649SpiroFitPF-T12026-03-06
00850000967007CMI HealthPC-900B2024-04-24
00850000967014CMI HealthPC-66L W412025-04-23
00850000967038CMI HealthPC-66L2025-04-23
00850000967052CMI HealthPC-66L W722025-04-23
00850000967311CMI HealthCH-1002025-01-17
00850000967304OxyKnightCF-1002024-07-03
00850000967410OxyKnightCF-100A2024-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410746CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410753CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410760CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410777CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410784CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410791CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410807CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09