FDA.reportPublic FDA data

BIS Advance

Primary DI
10884521852273
Brand
BIS Advance
Company
Covidien LP
Model
PMC80CB
Device description
BIS (TM) Advance pEEG Module
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORTBurst suppression detection software for electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260907000BIS™ Advance pEEG ModuleCovidien LP2026-08-13OLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521852273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452185227310884521852273

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia depth monitorA mains electricity (AC-powered) device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anaesthesia), showing the degree of consciousness. It is based upon the bispectral index (BIS) analysis of the electroencephalogram waveform and other features of this, enabling detection of, e.g., levels of sedation, loss of consciousness, and recall. It is used during anaesthesia administration and in trauma.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Fragile, Keep dry, This side up
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521783829LigaSureMRASILF192026-10-23
10884521853812Shiley1108602026-10-25
10884521853829Shiley1108652026-10-25
10884521853836Shiley1108702026-10-25
10884521853843Shiley1108752026-10-25
10884521853850Shiley1108802026-10-25
10884521853867Shiley1108852026-10-25
10884521853874Shiley1108902026-10-25
10884521856547Touch SurgeryMDS300282026-10-23
10884521861114Vital SyncVITALSYNCSW032026-10-25
10884521039902Surgipro llVPF-703-MX2015-09-02
10884521063433Ti-CronX-11362015-09-02
10884521073951Versaport PlusNB8STF2016-09-24
10884521195677Surgipro IIVP-653-MX2015-09-02
10884521546349Surgipro IIVP86X2016-09-24
10884521701991MonosofCN793G2017-10-10
10884521702073Surgipro IIVP746XG2017-10-10
10884521702172SurgiproCP41G2017-10-10
10884521705173SurgiproSP690G2017-06-23
10884521171534Nellcor10005941-SG2022-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.ORT2026-09-04
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyORT2026-04-15
00885797019837OrthonolRmo, Inc.ORT2024-08-18
00000008857972RMORmo, Inc.ORT2024-08-12
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCORT2024-05-13
10884521808270BISCovidien LPORT2024-04-28
10884521808300BISCovidien LPORT2024-04-28
10884521808317BISCovidien LPORT2024-04-28
B485CNSENV1000CNS EnvisionNATUS NEUROLOGY INCORPORATEDORT2023-08-18
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyORT2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyORT2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyORT2023-04-19
00195278524089NAGE Healthcare Finland OyORT2023-04-19
00195278466662E-EEGXGE Healthcare Finland OyORT2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyORT2022-07-01
00840682146111CARESCAPE B650GE Healthcare Finland OyORT2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyORT2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyORT2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12