αCare SENS ACS-000000-LS

GUDID 07290114061186

ALPHA OMEGA ENGINEERING CO. LTD.

Medical equipment clinical data interfacing software
Primary Device ID07290114061186
NIH Device Record Keye9bd0893-9da4-4465-8fd8-4790d814bf64
Commercial Distribution StatusIn Commercial Distribution
Brand NameαCare SENS
Version Model NumberαCare SENS
Catalog NumberACS-000000-LS
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290114061186 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

On-Brand Devices [αCare SENS]

07290114061186αCare SENS
07290114061179αCare SENS

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