BTP-1000A

GUDID B146BTPA20

BRAEMAR MANUFACTURING, LLC

Electrocardiographic lead set, reusable
Primary Device IDB146BTPA20
NIH Device Record Keyf376b5da-51b3-4cae-b5f7-b0964c35c06d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBTP-1000A
Version Model Number02-01576
Company DUNS049529118
Company NameBRAEMAR MANUFACTURING, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
HIBCCB146BTPA20 [Primary]

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-24
Device Publish Date2020-07-16

On-Brand Devices [BTP-1000A]

B146BTPA2002-01576
B146BTPA1002-00143

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