FDA.reportPublic FDA data

Bose Frames

Primary DI
00017817810012
Brand
Bose Frames
Company
BOSE CORPORATION
Model
BMD0010
Catalog number
839767-0110
Device description
Tempo 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
10017817810019PackageGS18In Commercial Distribution
20017817810016PackageGS120In Commercial Distribution
00017817810012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001781781001910017817810019
2001781781001620017817810016
00017817810012000178178100120178178100120017817810012

GMDN Terms#

Term, Definition table
TermDefinition
Tinted spectacle lens, non-prescriptionAn ophthalmic device made of a treated glass or plastic that is used to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light, but not to provide refractive corrections. 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

Sterilization Methods#

Method table
Method

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
00017817819978Bose Frames BMD0011851338-01102021-01-29
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
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
08435736091299ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091336ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091374ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091411ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091459ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091497ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091534ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091572ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091619ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091657ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091695ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091732ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091770ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091817ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091855ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091893ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091930ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091978ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736092012ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736092050ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002178ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002215ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002253ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002291ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002338ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002376ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002413ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002451ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002499ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002574ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08