FDA.reportPublic FDA data

IDEAL LIFE BP-Manager™

Primary DI
10804084000010
Brand
IDEAL LIFE BP-Manager™
Company
Ideal Life Inc
Model
BPM 0001
Published
2016-09-23
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
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060504000IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001Ideal Life, Inc.2006-03-14DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10804084000027PackageGS124In Commercial Distribution
10804084000034PackageGS112In Commercial Distribution
10804084000010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080408400002710804084000027
1080408400003410804084000034
1080408400001010804084000010

GMDN Terms#

Term, Definition table
TermDefinition
Manual-inflation electronic sphygmomanometer, portableAn electrically-powered device designed to noninvasively measure blood pressure using a manually-inflated cuff that typically fits around a limb (arm or thigh). It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height57Millimeter
Length154Millimeter
Weight429Gram
Width94Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 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
Serial number
true

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
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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