Ambulatory Blood Pressure Monitor

GUDID 06944413812697

Edan Instruments, Inc.

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Primary Device ID	06944413812697
NIH Device Record Key	ca2d0f42-61ba-4fec-a3a8-fad59ac6882b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ambulatory Blood Pressure Monitor
Version Model Number	SA-09
Company DUNS	529173163
Company Name	Edan Instruments, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413812581 [Primary]
GS1	06944413812697 [Package] Contains: 06944413812581 Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K210139

FDA Product Code

DXN	System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-29
Device Publish Date	2023-06-21

On-Brand Devices [Ambulatory Blood Pressure Monitor]

06944413812673	SA-05
06944413812666	SA-06
06944413812659	SA-08
06944413812697	SA-09
06944413812680	SA-10