FDA.reportPublic FDA data

SnapshotNIR

Primary DI
B376KD2050
Brand
SnapshotNIR
Company
Kent Imaging Inc
Model
KD205
Device description
Tissue oxygenation imaging device
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B376KD2050PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246859016
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B376KB1000SnapshotGLOKB1002025-07-10
B376KB100D0Drape KB100 SeriesKB100D2025-07-10
B376KD2040SnapshotNIRKD2042020-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10884521824409INVOSCovidien LPMUD2023-11-03
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