FDA.reportPublic FDA data

IDEAL LIFE SPO2 Manager™

Primary DI
00804084000105
Brand
IDEAL LIFE SPO2 Manager™
Company
Ideal Life Inc
Model
POM 0001
Published
2016-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
10804084000102PackageGS1200In Commercial Distribution
00804084000105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080408400010210804084000102
00804084000105008040840001058040840001050804084000105

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-888-433-2541info@ideallife.com

Regulatory Flags#

DUNS number
205155174
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10804084000065IDEAL LIFE SPO2 Manager™POM 00012016-11-18
10804084000010IDEAL LIFE BP-Manager™BPM 00012016-09-23
00804084000112IDEAL LIFE BP-Manager™BPM 00012017-04-21
30804084000144IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test StripsAGS-11122019-08-02
00804084000150IDEAL LIFE Control Solution Level IIGCS01042019-07-17
00804084000143IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)AGS-1112 2019-07-22
10804084000102IDEAL LIFE SPO2 Manager™POM 00012016-12-02

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Primary DI, Brand, Company table
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10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
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09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
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08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03