Arm Cuff Standard D-Ring Cuff 9"-13" H-CR17CAN

GUDID 00073796173142

Arm Blood Pressure Cuff, Standard D-ring (9" to 13")

Omron Healthcare, Inc.

Blood pressure cuff, reusable
Primary Device ID00073796173142
NIH Device Record Key6325e28a-6d0f-4c4f-9a69-73928a35c9f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameArm Cuff Standard D-Ring Cuff 9"-13"
Version Model NumberH-CR17CAN
Catalog NumberH-CR17CAN
Company DUNS054318779
Company NameOmron Healthcare, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

Phone1-800-634-4350
Emailquality@omron.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796173142 [Primary]
GS110073796173149 [Package]
Package: Case [20 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 Number4
Public Version Date2019-07-22
Device Publish Date2016-09-16

On-Brand Devices [Arm Cuff Standard D-Ring Cuff 9"-13"]

00073796838249Arm Blood Pressure Cuff (D-ring 9" to 13")
00073796173142Arm Blood Pressure Cuff, Standard D-ring (9" to 13")

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.