FDA.reportPublic FDA data

Bose Frames

Primary DI
00017817819978
Brand
Bose Frames
Company
BOSE CORPORATION
Model
BMD0011
Catalog number
851338-0110
Device description
Tenor style prescription ready sunglasses.
Published
2021-01-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10017817819975PackageGS18Not in Commercial Distribution
20017817819972PackageGS120Not in Commercial Distribution
00017817819978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001781781997510017817819975
2001781781997220017817819972
00017817819978000178178199780178178199780017817819978

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-877-230-5639xx@xx.xx

Regulatory Flags#

DUNS number
002579431
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017817812818Bose Frames BMD0005833416-010R2021-07-08
00017817812825Bose Frames BMD0006833417-010R2021-07-08
00017817820714Bose Frames BMD0011851336-01102021-01-29
00017817822053Bose Frames BMD0007840667-010R2021-07-08
00017817826716Bose Frames BMD0010839767-0110R2022-01-14
00017817827522Bose Frames BMD0011851336-011R2022-03-31
00017817827546Bose Frames BMD0011851338-0110R2022-01-14
00017817839518Bose Frames BMD0007840667-01002022-01-14
00017817839525Bose Frames BMD0010839767-01102022-01-14
00017817839532Bose Frames BMD0011851336-0112022-01-14
00017817839549Bose Frames BMD0011851338-01102022-01-14
00017817839556Bose Frames BMD0005833416-01002022-01-14
00017817810012Bose Frames BMD0010839767-01102021-01-29
00017817805698Bose Frames BMD0006833417-01002020-09-30
00017817805704Bose Frames BMD0005833416-01002020-09-30
00017817806657Bose Frames BMD0004834495-01002020-09-30
00017817806664Bose Frames BMD0003834494-01002020-09-30
00017817811538Bose Frames BMD0007840667-01002020-09-30
00017817827416Bose SoundControl Hearing AidBMD0012861812-03002021-05-18
00017817831918Bose Hear App865924-00102021-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973541158315SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158322SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158339SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158346SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
08800332269951Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-02
00676190876697Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876734Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876772Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539937Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539975Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814540018Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
08908016666505SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666529SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666536SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666635SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
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