FDA.reportPublic FDA data

Video laryngoscope aBlade kit

Primary DI
00612649181264
Brand
Video laryngoscope aBlade kit
Company
King Systems Corporation
Model
KVLABKIT3
Catalog number
KVLABKIT3
Device description
King Vision aBlade Kit Complete with 1 Vision Display,4 channeled aBlades 2 standard aBlades, case and AAA batteries
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGHLaryngoscope kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGHLaryngoscope KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612649182100PackageGS110In Commercial Distribution
00612649181264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649182100006126491821006126491821000612649182100
00612649181264006126491812646126491812640612649181264

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
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
00612649201238UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-8021ZD395-8021Z2016-09-22
00612649201283UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD440-6121ZD440-6121Z2016-09-22
00612649201306UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD440-80ZD440-80Z2016-09-22
00612649201337UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD445-80ZD445-80Z2016-09-22
00612649201597UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD465-80ZD465-80Z2016-09-22
00612649201610UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD465V-8021ZD465V-8021Z2016-09-22
00612649201627UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD466-6121ZD466-6121Z2016-09-22

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