FDA.reportPublic FDA data

Vasomedical-Biox™ CB Series Analysis & Reporting S/w - 3 & 12 CH ECG & ABP

Primary DI
00817980020160
Brand
Vasomedical-Biox™ CB Series Analysis & Reporting S/w - 3 & 12 CH ECG & ABP
Company
VASOMEDICAL, INC.
Model
CB Series S/W
Catalog number
A10-0036
Device description
CB Series Analysis & Reporting S/W - 3 & 12 CH ECG & Combined ABPM
Published
2016-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSHRECORDER, MAGNETIC TAPE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111180000VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORYVasomedical, Inc.2011-06-28DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817980020160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817980020160008179800201608179800201600817980020160

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyser application softwareA dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)508-5818eohara@vasomedical.com

Regulatory Flags#

DUNS number
197210248
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008179800205592GB SD Memory CardModel 1303A10-00112016-11-29
008179800205663-Ch ECG Holter Patient Cable w/5 LeadsModel 1303A10-00522016-11-29
008179800205733-Ch ECG Holter Patient Cable w/7 LeadsModel 1303A10-00532016-11-29
0081798002058012-Ch ECG Holter Patient Cable w/10 LeadsModel 1304A10-00542016-11-29
00817980020597USB SD Card ReaderModel 1303A10-00152016-11-29
00817980020603Infared Communication AdaptorModel 1805A10-00222016-11-29
00817980020610Portable Case w/Belt for 1303 RecorderModel 1303A10-00412016-11-29
00817980020627Portable case with Belt for 1304/1305 RecorderModel 1304A10-00422016-11-29
00817980020634Portable case with Belt for 1805 MonitorModel 1303A10-00502016-11-29
00817980020641Portable case with Belt for 2301/2302 RecordersModel 2301A10-00432016-11-29
008179800208703 Lead Integrated ECG Cable (AngioNew® V & VI)Model AngioNew VIA12-00332016-11-29
008179800208873 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™)Model LumenairV10-00172016-11-29
008179800208943 Lead Integrated ECG Cable with adapter (Model TS3)Model TS3V10-00212016-11-29
00817980020900ECG Cable Adaptor-for use with V10-0017 (Model TS3)Model TS3V83-00662016-11-29
00817980021198Finger Plethysmograph (Models TS3 and TS4)Model TS-4V83-00062016-11-29
00817980021204Finger Plethysmograph (Model MC2, AngioNew® V& VI)Model AngioNew VIV23-00072016-11-29
00817980021402Vasomedical™ EZ™ O2 A Adult Pulse OximeterModel EZA13-0002-03-012016-11-29
00817980021419Vasomedical™ EZ™ O2 P Adult/Pediatric Pulse OximeterModel EZA13-0002-05-012016-11-29
00817980021426Vasomedical™ EZ™ Pediatric Probe for EZ™ O2 P (children over 3 yrs & Sm.Adults)Model EZA13-00702016-11-29
00817980021433Vasomedical™ EZ™ O2 Wrist Pulse OximeterModel EZA13-0002-02-012016-11-29

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