Portable case with Belt for 1805 Monitor A10-0050

GUDID 00817980020634

Portable case with Belt for 1805 Monitor

VASOMEDICAL, INC.

Electrocardiographic lead set, reusable
Primary Device ID00817980020634
NIH Device Record Key05da94fc-90c4-4bc1-a3a7-2888853c2026
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortable case with Belt for 1805 Monitor
Version Model NumberModel 1303
Catalog NumberA10-0050
Company DUNS197210248
Company NameVASOMEDICAL, 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 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

Customer Support Contacts

Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817980020634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSHRECORDER, MAGNETIC TAPE, MEDICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-29

Devices Manufactured by VASOMEDICAL, INC.

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00817980020016 - Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter Recorder2019-11-08 3 CH ECG Holter ULTRA Recorder
00817980020023 - Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder2019-11-08 12 CH ECG Holter Recorder
00817980020030 - Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder2019-11-08 12 CH ECG Holter Ultra Recorder
00817980020047 - Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W2019-11-08 Ambulatory Blood Pressure Recorder
00817980020054 - Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W2019-11-08 Ambulatory Blood Pressure Recorder
00817980020061 - Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth2019-11-08 Ambulatory Blood Pressure Recorder w/Bluetooth
00817980020078 - Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor2019-11-08 3 CH ECG Holter/ABP COMBINED Recorder

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