FDA.reportPublic FDA data

King Vision Video Laryngoscope

Primary DI
00612649209401
Brand
King Vision Video Laryngoscope
Company
King Systems Corporation
Model
KVLAB2
Catalog number
KVLAB2
Device description
King Vision aBlade size 2 Standard
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00612649208336PackageGS120In Commercial Distribution
00612649209371PackageGS13In Commercial Distribution
00612649209401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649208336006126492083366126492083360612649208336
00612649209371006126492093716126492093710612649209371
00612649209401006126492094016126492094010612649209401

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laryngopharyngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
009299017
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612649217604ADULT ULTRA FLEX®95509955092026-08-21
00612649217628PEDIATRIC ULTRA FLEX®96609966092026-08-21
00612649217642ADULT ULTRA FLEX®95510955102026-08-21
00612649217666ADULT ULTRA FLEX®95511955112026-08-21
00612649217680PEDIATRIC ULTRA FLEX®J21814-13621J21814-136212026-08-21
00612649217703PEDIATRIC ULTRA FLEX®J2904-13621J2904-136212026-08-21
00612649217727ADULT ULTRA FLEX®J81213F-13621J81213F-136212026-08-21
00612649196398ADULT ANESTHESIABREATHING CIRCUIT8403F-80Z8403F-80Z2016-09-22
00612649198552ADULT ANESTHESIA8600B-848600B-842020-10-21
00612649198651ADULT ANESTHESIABREATHING CIRCUIT8603F-6121Z8603F-6121Z2016-09-22
00612649198668ADULT ANESTHESIABREATHING CIRCUIT8603F-61Z8603F-61Z2016-09-22
00612649200033UNIVERSAL F2®C0120-230C0120-2302022-12-13
00612649200071UNIVERSAL F2®C060-230C060-2302023-01-16
00612649200118UNIVERSAL F2®C090-230C090-2302022-12-13
00612649200125UNIVERSAL F2®C090-61C090-612022-12-13
00612649200149UNIVERSAL F2®C360-61ZC360-61Z2022-12-13
00612649200323ADULT ANESTHESIABREATHING CIRCUITCP-01084CP-010842016-09-22
00612649200934UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD360-808ZD360-808Z2016-09-22
00612649201078UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD366-618ZD366-618Z2016-09-22
00612649201214UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-16421ZD395-16421Z2016-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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