FDA.reportPublic FDA data

BRITEVIEW

Primary DI
10850012936920
Brand
BRITEVIEW
Company
Hartwell Medical LLC
Model
LB 51MIL4-DS
Catalog number
LB 51MIL4-DS
Device description
Color-coded disposable LED laryngoscope blade (Miller 4 - Lime)
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
00850012936923PrimaryGS10
10850012936920Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012936923008500129369238500129369230850012936923
1085001293692010850012936920

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, single-useThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted 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 is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-633-5900customerservice@hartwellmedical.com

Regulatory Flags#

DUNS number
119028339
Device count
10
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
false
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
00850012936022BRITEVIEWLB 51MAC1-DSLB 51MAC1-DS2023-08-30
00850012936039BRITEVIEWLB 51MAC2-DSLB 51MAC2-DS2023-08-30
00850012936046BRITEVIEWLB 51MAC3-DSLB 51MAC3-DS2023-08-30
00850012936053BRITEVIEWLB 51MAC4-DSLB 51MAC4-DS2023-08-30
00850012936060BRITEVIEWLB 51MIL0-DSLB 51MIL0-DS2023-08-30
00850012936077BRITEVIEWLB 51MIL1-DSLB 51MIL1-DS2023-08-30
00850012936084BRITEVIEWLB 51MIL2-DSLB 51MIL2-DS2023-08-30
00850012936091BRITEVIEWLB 51MIL3-DSLB 51MIL3-DS2023-08-30
00850012936695GRANDVIEWGV 2020A-DSGV 2020A-DS2023-08-30
00850012936923BRITEVIEWLB 51MIL4-DSLB 51MIL4-DS2023-08-30
10850012936029BRITEVIEWLB 51MAC1-DSLB 51MAC1-DS2023-08-30
10850012936036BRITEVIEWLB 51MAC2-DSLB 51MAC2-DS2023-08-30
10850012936043BRITEVIEWLB 51MAC3-DSLB 51MAC3-DS2023-08-30
10850012936050BRITEVIEWLB 51MAC4-DSLB 51MAC4-DS2023-08-30
10850012936067BRITEVIEWLB 51MIL0-DSLB 51MIL0-DS2023-08-30
10850012936074BRITEVIEWLB 51MIL1-DSLB 51MIL1-DS2023-08-30
10850012936081BRITEVIEWLB 51MIL2-DSLB 51MIL2-DS2023-08-30
10850012936098BRITEVIEWLB 51MIL3-DSLB 51MIL3-DS2023-08-30
00850012936657GRANDVIEWGV 1001GV 10012023-08-30
00850012936664GRANDVIEWGV 1002GV 10022023-08-30

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Primary DI, Brand, Company table
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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
08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
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G1414046440Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
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