E+R

Basic Information

• Brand Name: E+R
• Primary DI: 01697038425005
• Version / Model: LD-737
• Company Name: HONSUN (NANTONG) CO.,LTD
• Labeler DUNS: 543364560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-27
• Public Version: 1
• Public Version Date: 2020-10-05
• Public Version Status: New
• Public Device Record Key: 685d3035-be4a-4bbb-9eed-93471f7beb8b

Device Characteristics

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

GMDN Terms

Code	Name	Definition	Implantable	Status
16986	Automatic-inflation electronic sphygmomanometer, portable, finger	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic finger-cuff inflation and measurement cycles. The cuff detects minute arterial volume changes in conjunction with an inflatable bladder which exerts pressure (counterpressure) just sufficient to equal the arterial pressure. The device typically displays current heart rate in addition to systolic and diastolic blood pressures. 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	01697038425005	GS1

Premarket Submissions

Submission Number	Supplement Number
K131463	000