DL900

GUDID B146DL9280

BRAEMAR MANUFACTURING, LLC

Electrocardiographic ambulatory recorder
Primary Device IDB146DL9280
NIH Device Record Key34e65dce-b9e2-49de-879e-9917d634e253
Commercial Distribution StatusIn Commercial Distribution
Brand NameDL900
Version Model Number900-0570-28
Company DUNS049529118
Company NameBRAEMAR MANUFACTURING, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB146DL9280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWJElectrocardiograph, Ambulatory (Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-30
Device Publish Date2020-01-22

On-Brand Devices [DL900]

B146DL9ZW0900-0570-25
B146DL9280900-0570-28

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