FDA.reportPublic FDA data

FORE-SIGHT ELITE®

Primary DI
10609538711012
Brand
FORE-SIGHT ELITE®
Company
CAS MEDICAL SYSTEMS, INC.
Model
01-07-1101
Device description
Tissue Oximeter Sensor Small
Published
2017-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K143675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143675000FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015-04-10MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30609538711016PackageGS120In Commercial Distribution
10609538711012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3060953871101630609538711016
1060953871101210609538711012

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeter sensor, single-useA photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement 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. It is connected to a tissue saturation oximeter via a fibreoptic cable and will typically include a light shield to protect the measurements from ambient light. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Centimeter

Regulatory Flags#

DUNS number
122211543
Device count
1
Lot or batch
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
10609538611008FORE-SIGHT ELITE01-06-11002018-12-12
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
10609538711029FORE-SIGHT ELITE®01-07-11022017-03-06
10609538711036FORE-SIGHT ELITE®01-07-11032017-03-06

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