PRO-Diary 05-111

GUDID B329PDM25

Ambulatory Physical Activity Recorder with Electronic Patient diary

CAMNTECH LIMITED

Kinesiology ambulatory recorder
Primary Device IDB329PDM25
NIH Device Record Keyde9c8ce1-401d-45cb-a104-c79a3886e680
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRO-Diary
Version Model NumberPDM
Catalog Number05-111
Company DUNS399114941
Company NameCAMNTECH LIMITED
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 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

Customer Support Contacts

Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB329PDM25 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LELDevice, Sleep Assessment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-05
Device Publish Date2016-09-24

On-Brand Devices [PRO-Diary]

B329PDM25Ambulatory Physical Activity Recorder with Electronic Patient diary
B329PDV25Ambulatory Physical Activity Recorder with Electronic Patient diary

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