FDA.reportPublic FDA data

Insighters

Primary DI
06970831723024
Brand
Insighters
Company
Shenzhen Insighters Medical Technology Co., Ltd.
Model
insight iS2
Published
2022-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06970831723024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970831723024069708317230246970831723024

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope handle/monitorA non-sterile component of a bladed video intubation laryngoscope intended to enable the positioning of the blade into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a monitor for the user to view anatomical images of the larynx/trachea transmitted by a video system from an electronic camera at the distal end of the blade. This is a reusable device.

Regulatory Flags#

DUNS number
551096917
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970831723659InsightersVisible Left type 28Fr2026-04-14
06970831723666InsightersVisible Left type 32Fr2026-04-14
06970831723673InsightersVisible Left type 35Fr2026-04-14
06970831723680InsightersVisible Left type 37Fr2026-04-14
06970831723697InsightersVisible Left type 39Fr2026-04-14
06970831723703InsightersVisible Left type 41Fr2026-04-14
06970831723710InsightersVisible Right type 28Fr2026-04-14
06970831723727InsightersVisible Right type 32Fr2026-04-14
06970831723734InsightersVisible Right type 35Fr2026-04-14
06970831723741InsightersVisible Right type 37Fr2026-04-14
06970831723758InsightersVisible Right type 39Fr2026-04-14
06970831723765InsightersVisible Right type 41Fr2026-04-14
06970831723772InsightersVisible Left type B 28Fr2026-04-14
06970831723789InsightersVisible Left type B 32Fr2026-04-14
06970831723796InsightersVisible Left type B 35Fr2026-04-14
06970831723802InsightersVisible Left type B 37Fr2026-04-14
06970831723819InsightersVisible Left type B 39Fr2026-04-14
06970831723826InsightersVisible Left type B 41Fr2026-04-14
06970831723833InsightersVisible Right type B 28Fr2026-04-14
06970831723840InsightersVisible Right type B 32Fr2026-04-14

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04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
00842209139149NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
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