Central Hub CMS

GUDID 00850064210163

Central Hub CMS

Sibel Health Inc.

Wearable multiple vital physiological parameter monitor
Primary Device ID00850064210163
NIH Device Record Keyec1b7ad4-e306-4ee0-a32b-345bc3cea7ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameCentral Hub CMS
Version Model Number900-00013
Company DUNS093772547
Company NameSibel Health 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 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
GS100850064210163 [Primary]

FDA Product Code

MSXSystem, Network And Communication, Physiological Monitors

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-04
Device Publish Date2025-03-27

Devices Manufactured by Sibel Health Inc.

00850064210200 - Sibel Spacelabs Trek Chest Patch2025-04-10
00850064210217 - Sibel Spacelabs Trek Finger Patch2025-04-10
00850064210224 - Sibel Spacelabs Trek Charger2025-04-10
00850064210231 - Sibel Spacelabs Finger Patch Adhesive 3 day2025-04-10
00850064210248 - Sibel Spacelabs Trek Chest Patch Adhesive2025-04-10
00850064210255 - Sibel Spacelabs Trek Blood Pressure Cuff2025-04-10
00850064210262 - Sibel Spacelabs Trek Tablet2025-04-10
00860004541745 - ANNE Chest2025-04-10 The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activ

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