Omron 3 Series Wrist Blood Pressure Monitor BP6100

GUDID 10073796266100

Wrist blood pressure monitor with 5.3" to 8.5" cuff; 60 memory storage.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID10073796266100
NIH Device Record Key610abfc3-9575-474c-be29-0cf4e87357e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron 3 Series Wrist Blood Pressure Monitor
Version Model NumberBP6100
Catalog NumberBP6100
Company DUNS054318779
Company NameOmron Healthcare, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-634-4359
Emailohiquality@omron.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796266103 [Primary]
GS110073796266100 [Package]
Contains: 00073796266103
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-04-29

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