FDA.reportPublic FDA data

IDEAL LIFE SPO2 Manager™

Primary DI
10804084000102
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
Rx
false
OTC
true
Sterile
false
Single use
false

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 applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
205155174
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
false
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
00804084000105IDEAL LIFE SPO2 Manager™POM 00012016-12-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
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06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
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06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09