FDA.reportPublic FDA data

BritePro Solo Single-Use Fiber Optic Handle and Blade Kessel 3

Primary DI
05055788700432
Brand
BritePro Solo Single-Use Fiber Optic Handle and Blade Kessel 3
Company
FLEXICARE MEDICAL LIMITED
Model
040-01-0730U
Published
2020-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
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
05055788700432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788700432050557887004325055788700432

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, single-useA hand-held disposable device intended to be used by anaesthesia/emergency service personnel 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 handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055788776246ProVu Video Stylet038-995-065U038-995-065U2025-05-30
05055788776260ProVu Video Stylet038-995-070U038-995-070U2025-05-30
05055788776284ProVu Video Stylet038-995-075U038-995-075U2025-05-30
05055788776307ProVu Video Stylet038-995-080U038-995-080U2025-05-30
05055788721499Flexicare040-836U2024-11-21
05055788721550Flexicare040-835U2024-11-21
05055788721802Flexicare040-831U2024-11-21
15055788722462BriteBlade Pro Evo Single-Use Fiber Optic Miller 4040-764U2024-08-07
15055788722486BriteBlade Pro Evo Single-Use Fiber Optic Miller 3040-763U2024-08-07
15055788722509BriteBlade Pro Evo Single-Use Fiber Optic Miller 2040-762U2024-08-07
15055788722523BriteBlade Pro Evo Single-Use Fiber Optic Miller 1040-761U2024-08-07
15055788722561BriteBlade Pro Evo Single-Use Fiber Optic Mac 4040-754U2024-08-07
15055788722585BriteBlade Pro Evo Single-Use Fiber Optic Mac 2040-753U2024-08-07
15055788722608BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-752U2024-08-07
15055788722622BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-751U2024-08-07
05055931127888Flexicare032-10-180LU2024-07-17
05055931127895Flexicare032-10-181LU2024-07-17
05055931127901Flexicare032-10-182LU2024-07-17
05055931127918Flexicare010-762LU2024-07-17
05055931104162ProVu040-08-0420U2024-06-24

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Primary DI, Brand, Company table
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00198506087875ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
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00198506085727ELMED INCORPORATEDELMED INCORPORATEDCCW2025-09-19
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