FDA.reportPublic FDA data

BIS

Primary DI
10884521128774
Brand
BIS
Company
Covidien LP
Model
186-0157-RFB
Device description
Digital Signal Converter, DSC-XP,Refurbished
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLWIndex-generating electroencephalograph software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLWIndex-Generating Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062613000BIS EEG MONITOR VIEWAspect Medical Systems, Inc.2007-06-18OLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521128774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452112877410884521128774

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp leadA wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00690103219609VitaWaveEdwards Lifesciences LLCOLW2025-09-10
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCOLW2024-05-13
10884521808270BISCovidien LPOLW2024-04-28
10884521808300BISCovidien LPOLW2024-04-28
10884521808317BISCovidien LPOLW2024-04-28
10884521533103BISCovidien LPOLW2024-03-01
00690103218848HemoSphere VitaEdwards Lifesciences LLCOLW2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCOLW2024-02-26
10843997012802RD SedlineMASIMO CORPORATIONOLW2023-08-22
00843997013475SedLineMASIMO CORPORATIONOLW2023-08-22
00843997013895SedLineMASIMO CORPORATIONOLW2023-08-22
00843997012805RD SedlineMASIMO CORPORATIONOLW2023-08-22
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyOLW2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyOLW2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyOLW2023-04-19
00195278524089NAGE Healthcare Finland OyOLW2023-04-19
10884521713055BISCovidien LPOLW2023-01-21
B746NS90101NeuroSENSENeurowave Systems Inc.OLW2022-10-21
10884521812376BISCovidien LPOLW2022-09-24
00840682146111CARESCAPE B650GE Healthcare Finland OyOLW2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyOLW2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyOLW2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12