FDA.reportPublic FDA data

Pulse Oximeter

Primary DI
00616784708928
Brand
Pulse Oximeter
Company
Dynarex Corporation
Model
7089
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090599000MD300K1 PULSE OXIMETERBeijing Choice Electronic Technololgy Co., Ltd.2009-07-20DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784708935PackageGS110In Commercial Distribution
00616784708928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784708935006167847089356167847089350616784708935
00616784708928006167847089286167847089280616784708928

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.

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Serial number
true

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