FDA.reportPublic FDA data

BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for

Primary DI
05055788773559
Brand
BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for
Company
FLEXICARE MEDICAL LIMITED
Model
041-814U
Device description
BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for Mini/Penlight Handle
Published
2020-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05055788773559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788773559050557887735595055788773559

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope light-emitting cellA non-sterile, portable, battery-powered device intended to provide the light source for a laryngoscope (i.e., rigid intubation type) when fitted into the laryngoscope handle. It typically consists of a removable cylindrical cell that produces light which is emitted from the laryngoscope handle via a fibreoptic laryngoscope blade for airway illumination. The device may be kinetically or electrically recharged. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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05055931102113Maxineb Duo Nebulizer + Mouthpiece, Tubing And Filter032-10-039U2020-03-27

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