FDA.reportPublic FDA data

BritePro Single-Use Fiber Optic Lightsource

Primary DI
05055788722243
Brand
BritePro Single-Use Fiber Optic Lightsource
Company
FLEXICARE MEDICAL LIMITED
Model
040-792U
Device description
BritePro Single-Use Fiber Optic Lightsource
Published
2020-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05055788722243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788722243050557887222435055788722243

GMDN Terms#

Term, Definition table
TermDefinition
Intubation light sourceA device designed as a handle containing a light source used to provide cold light illumination for a patient's airways during access, intubation, and airway management. It is a pistol-grip-like device that contains the batteries that provide energy for the airway-illuminating lighting for the attached fibreoptic stylet and an illumination source (e.g., a halogen light bulb). This device is used together with other devices, e.g., stylets, oxygen (O2) connectors, a camera adaptor, typically to manage and document difficult airway intubations. 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055788767640Leg Bag Holder Extra Large00-0038U2020-03-25
05055788767671Leg Bag Holder Large00-0037U2020-03-25
05055788767701Leg Bag Holder Medium00-0036U2020-03-25
05055788767732Leg Bag Holder Small00-0035U2020-03-25
05055788787044Flexicare040-11-0000U2026-03-31
05055788787068Flexicare040-12-0130U2026-03-31
05055788787082Flexicare040-12-0140U2026-03-31
05055788787105Flexicare040-12-2130U2026-03-31
05055788787129Flexicare040-12-2135U2026-03-31
05055788787143Flexicare040-12-2140U2026-03-31
05055788791317Flexicare030-620/1U2024-03-13
05055931101963Maxineb Duo Filter Pad032-10-021U2020-03-27
05055931101970Maxineb Duo032-10-031U2020-03-27
05055931101994Maxineb Duo Nebulizer + Mouthpiece032-10-033U2020-03-27
05055931102014Maxineb Duo Nebulizer + Mouthpiece And Filter032-10-034U2020-03-27
05055931102038Maxineb Duo Filter032-10-035U2020-03-27
05055931102052Maxineb Duo Filter Master Case032-10-036U2020-03-27
05055931102076Maxineb Duo Nebulizer And Tubing032-10-037U2020-03-27
05055931102090Maxineb Duo Nebulizer + Mouthpiece And Tubing032-10-038U2020-03-27
05055931102113Maxineb Duo Nebulizer + Mouthpiece, Tubing And Filter032-10-039U2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251346Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251353Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251360Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251377Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251384Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251391Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251414Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251421Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251445Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251452Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251469Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251476Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251483Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251490Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251506Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257744Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257768Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257782Surgical DesignSurgical Design, Inc.CCW2026-06-09
00879123009340GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
00879123009357GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
08436031030112AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030211AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030310AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030419AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030518AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030617AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033908AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01