FDA.reportPublic FDA data

BRITEVIEW

Primary DI
00850012936084
Brand
BRITEVIEW
Company
Hartwell Medical LLC
Model
LB 51MIL2-DS
Catalog number
LB 51MIL2-DS
Device description
Color-coded disposable LED laryngoscope blade (Miller 2 - Yellow)
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00850012936084PrimaryGS10
10850012936081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012936084008500129360848500129360840850012936084
1085001293608110850012936081

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

Contacts#

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

Regulatory Flags#

DUNS number
119028339
Device count
10
Premarket exempt
true
Lot or batch
true

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
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
10850012936692GRANDVIEWGV 2020A-DSGV 2020A-DS2023-08-30

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