FDA.reportPublic FDA data

Pulse Oximeter

Primary DI
6944413807914
Brand
Pulse Oximeter
Company
Edan Instruments, Inc.
Model
PO-100B
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
6944413807914PackageGS15In Commercial Distribution
06944413807822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6944413807914069444138079146944413807914
06944413807822069444138078226944413807822

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
529173163
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944413837164Diagnostic Ultrasound SystemNano L12 EXP2026-03-09
06944413837188Diagnostic Ultrasound SystemNano L122026-03-09
06944413837171Diagnostic Ultrasound SystemNano C52026-03-09
06944413836532Diagnostic Ultrasound SystemNano C5 EXP2026-03-09
06944413849570Holter ECG and ABP SystemHolterABP2026-03-02
06944413858664TOCO-MECG transducerTOCO-EF2026-02-06
06944413858671TOCO-MECG transducerTOCO-EA2026-02-06
06944413814714Trolley(For medical use)MT-5032025-12-09
06944413819726Trolley(For medical use)MT-8032025-12-09
06944413819733Trolley(For medical use)MT-8112025-12-09
06944413807112Remote Event Marker02.01.2100952025-11-29
06944413804197ECG Cable3-lead, 12-pin, Defib-proof, IEC, Snap2025-09-13
06944413815704ECG Cable6-lead, 12-pin, Defib-proof, Adult/pediatric2025-09-13
06944413815711ECG Cable6-lead, Clip, AHA, Adult/pediatric2025-09-13
06944413815728ECG Cable6-lead, Snap, AHA, Adult/pediatric2025-09-13
06944413815735ECG Cable6-lead, Clip, IEC, Adult/pediatric2025-09-13
06944413815742ECG Cable6-lead, Snap, IEC, Adult/pediatric2025-09-13
06944413838963C.O. AccessoriesConnection cable2025-09-14
06944413838406Patient Monitor CX102025-09-05
06944413838413Patient MonitorCX122025-09-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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