FDA.reportPublic FDA data

Smart VIdeo-Stylet Monitor

Primary DI
B881SSCNDK0
Brand
Smart VIdeo-Stylet Monitor
Company
SMART VIDEO-STYLET, LLC
Model
S-SC-NDK
Catalog number
S-SC-NDK
Device description
Monitor with connecting and re-charging cables, to be used with video-stylet (comes with IV pole mount)
Published
2020-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B881SSCNDK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid non-bladed video intubation laryngoscopeA non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It consists of a thin tubular portion inserted into the ET tube prior to intubation, with an electronic camera at its distal end to transmit anatomical images by a video system to a handle/monitor. It is typically made of memory-alloy material to allow moulding into a shape to facilitate intubation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113503058
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B881SSCVS1Smart Video-StyletS-SC-VSS-SC-VS2020-11-29
B881SSCVS0Smart Video-StyletS-SC-VSS-SC-VS2020-11-29

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