FDA.reportPublic FDA data

Ambu® SureSight® Mobile Kit

Primary DI
05707480163267
Brand
Ambu® SureSight® Mobile Kit
Company
Ambu A/S
Model
390471000
Catalog number
390471000
Device description
Portable Video Laryngoscope Kit
Published
2025-12-19
Public version status
New
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
05707480163274PackageGS12In Commercial Distribution
05707480163267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480163274057074801632745707480163274
05707480163267057074801632675707480163267

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.

Contacts#

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

Regulatory Flags#

DUNS number
305682023
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05707480024650Ambu® Mini Perfit ACE™0002811060002811062022-12-08
05707480024674Ambu® Immobilization Kit, with0002811610002811612022-12-08
05707480026197BlueSensor NEOXECG ElectrodesNEOX-60-K/US/3NEOX-60-K/US/32016-09-21
05707480024513Ambu® Perfit Collar™0002642010002642012022-12-08
05707480024520Ambu® Perfit Collar™0002642020002642022022-12-08
05707480024537Ambu® Perfit Collar™0002642030002642032022-12-08
05707480024544Ambu® Perfit Collar™0002642040002642042022-12-08
05707480024551Ambu® Perfit Collar™0002642050002642052022-12-08
05707480024568Ambu® Perfit Collar™0002642060002642062022-12-08
05707480024575Ambu® Perfit Collar™0002645010002645012022-12-08
05707480024582Ambu® Perfit Collar™0002645020002645022022-12-08
05707480024599Ambu® Perfit Collar™0002645030002645032022-12-08
05707480024605Ambu® Perfit Collar™0002645040002645042022-12-08
05707480024612Ambu® Perfit Collar™0002645050002645052022-12-08
05707480024629Ambu® Perfit Collar™0002645060002645062023-02-09
05707480024636Ambu® Perfit ACE™0002810000002810002022-12-08
05707480024643Ambu® Military Perfit ACE™000281000MIL000281000MIL2022-12-08
05707480024667Ambu® Immobilization Kit, with0002811510002811512022-12-08
05707480037315Ambu® Immobilization Kit, with0002811520002811522022-12-08
05707480038619Ambu® Immobilization Kit, with0002811530002811532022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05707480163205Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163212Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163274Ambu® SureSight® Mobile KitAmbu A/SOGH2025-12-19
10197106816394CARDINAL HEALTHCardinal Health 200, LLCOGH2024-10-31
50197106816392CARDINAL HEALTHCardinal Health 200, LLCOGH2024-10-31
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50197106409013CARDINAL HEALTHCardinal Health 200, LLCOGH2023-08-31
00191072194480ACSAMERICAN CONTRACT SYSTEMS, INC.OGH2023-05-01
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00612649181264Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
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00612649182100Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
10195594579692CARDINAL HEALTHCardinal Health 200, LLCOGH2022-05-06
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10888439932447CARDINAL HEALTHCardinal Health 200, LLCOGH2021-10-07
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10195594321871CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-16
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