FDA.reportPublic FDA data

FORE-SIGHT ELITE

Primary DI
10609538611008
Brand
FORE-SIGHT ELITE
Company
CAS MEDICAL SYSTEMS, INC.
Model
01-06-1100
Device description
FORE-SIGHT ELITE Preamp / Module Clip
Published
2018-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180003000FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018-05-10MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609538611008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060953861100810609538611008

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeterA mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.

Regulatory Flags#

DUNS number
122211543
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10609538610001FORE-SIGHT ELITE01-06-10002018-12-12
10609538610018FORE-SIGHT ELITE01-06-10012018-12-12
10609538741033FORE-SIGHT ELITE01-07-41032018-12-12
10609538600057FORE-SIGHT®01-06-00052017-03-06
10609538600439FORE-SIGHT®01-06-00432017-03-06
10609538630009FORE-SIGHT ELITE®01-06-30002017-03-06
10609538630146FORE-SIGHT ELITE®01-06-30142017-03-06
10609538631006FORE-SIGHT ELITE®01-06-31002017-03-06
10609538631013FORE-SIGHT ELITE®01-06-31012017-03-06
10609538710008FORE-SIGHT®01-07-10002017-03-06
10609538710022FORE-SIGHT®01-07-10022017-03-06
10609538710039FORE-SIGHT®01-07-10032017-03-06
10609538710046FORE-SIGHT®01-07-10042017-03-06
10609538710053FORE-SIGHT®01-07-10052017-03-06
10609538710060FORE-SIGHT®01-07-10062017-03-06
10609538710077FORE-SIGHT®01-07-10072017-03-06
10609538711005FORE-SIGHT ELITE®01-07-11002017-03-06
10609538711012FORE-SIGHT ELITE®01-07-11012017-03-06
10609538711029FORE-SIGHT ELITE®01-07-11022017-03-06
10609538711036FORE-SIGHT ELITE®01-07-11032017-03-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCMUD2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCMUD2025-07-11
10884521845985INVOSCovidien LPMUD2025-07-03
00690103217957HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
10884521845039INVOSCovidien LPMUD2025-02-08
20884521845036INVOSCovidien LPMUD2025-02-08
00690103218879HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103211313ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211320ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211337ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211318ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211325ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211332ForeSightEdwards Lifesciences LLCMUD2024-08-26
10884521701243INVOSCovidien LPMUD2024-04-14
10884521557048INVOSCovidien LPMUD2024-04-14
B376KD2050SnapshotNIRKent Imaging IncMUD2024-04-05
00690103217124HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218848HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218862HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
10884521824409INVOSCovidien LPMUD2023-11-03
10884521824416INVOSCovidien LPMUD2023-11-03