FDA.reportPublic FDA data

BrightCare

Primary DI
00856614007757
Brand
BrightCare
Company
The Gilbert Group LLC
Model
SQ1209
Published
2024-08-29
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
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856614007757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856614007757008566140077578566140077570856614007757

GMDN Terms#

Term, Definition table
TermDefinition
Adult nappyA disposable undergarment (a nappy or diaper) composed of absorbent material and worn between the legs used to collect urine and faeces from an incontinent adult patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
075007395
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856614007863BrightCareSQ12202025-12-02
00856614007870BrightCareSQ12212025-12-02
00856614007887BrightCareSQ12222025-12-02
00856614007764BrightCareSQ12102024-08-29
00856614007771BrightCareSQ12112024-08-29
00856614007788BrightCareSQ12122024-08-29
00856614007795BrightCareSQ12132024-08-29
00856614007801BrightCareSQ12142024-08-29
00856614007818BrightCareSQ12152024-08-29
00856614007825BrightCareSQ12162024-08-29
00856614007832BrightCareSQ12172024-08-29
00852272007184BrightCare MedsoftSQ10432023-08-24
00852272007238BrightCare MedsoftSQ10482023-09-02
00852272007481BrightCareSQ10722023-09-02
00852272007504BrightCareSQ10742023-09-02
00852272007528BrightCareSQ10762023-09-02
00852272007542BrightCareSQ10782023-09-02
00852272007801BrightCareSQ11042023-09-02
00852272007825BrightCareSQ11062023-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810065846433WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846440WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846457WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846464WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846471WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846488WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010177WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010184WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010191WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010207WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010214WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010221WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010658WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010665WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010672WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010689WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010696WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010702WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010719WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010726WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010733WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010740WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011501WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011518WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011525WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011532WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011549WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011556WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011563WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011570WeareverPRIME LIFE FIBERSEYQ2025-09-23