IDEAL LIFE BP-Manager™

Basic Information

• Brand Name: IDEAL LIFE BP-Manager™
• Primary DI: 00804084000112
• Version / Model: BPM 0001
• Company Name: Ideal Life Inc
• Labeler DUNS: 205155174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-21
• Public Version: 5
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: d9ed899a-b7fe-41c4-8d9a-8ef21c50e247

Device Description

BP Manager

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47489	Manual-inflation electronic sphygmomanometer, portable	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00804084000112	GS1
Package	30804084000113	GS1		3	In Commercial Distribution
Package	40804084000110	GS1		4	In Commercial Distribution
Package	20804084000116	GS1		12	In Commercial Distribution
Package	10804084000119	GS1		24	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K060504	000

Device Sizes

Type	Value	Unit	Text
Length	154	Millimeter
Width	94	Millimeter
Height	57	Millimeter
Weight	429	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity