FDA.reportPublic FDA data

caring mill

Primary DI
00810025926854
Brand
caring mill
Company
Blue Echo Care LLC
Model
CM-PP-VOIV-PVOI
Device description
caring mill- Ear Wax Removal Irrigation Kit
Published
2024-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OGQEar Irrigation Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGQEar Irrigation KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810025926854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810025926854008100259268548100259268540810025926854

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation kit, reusableA collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manually-operated flushing device (e.g., spray bottle, syringe) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117048847
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00691835141008caring millCM-EE-VOIV-PVOI2024-06-20
00860007911446Cleanse RightCR-EARSPRLKIT-12024-06-20
00860007911453Cleanse RightCR-EARKIT-12024-06-20
00860007911460Cleanse RightCR-ELTRNEAR-12024-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16971919462535Medi GradeNingbo Albert Novosino Co.,Ltd.OGQ2025-12-29
16971919460500Medi GradeNingbo Albert Novosino Co.,Ltd.OGQ2025-11-20
00714646000675Ear Wax Removal KitBionix, LLCOGQ2024-07-11
00691835141008caring millBlue Echo Care LLCOGQ2024-06-20
00860007911446Cleanse RightBlue Echo Care LLCOGQ2024-06-20
00860007911453Cleanse RightBlue Echo Care LLCOGQ2024-06-20
00860007911460Cleanse RightBlue Echo Care LLCOGQ2024-06-20
10714646000672Ear Wax Removal Kit 12 Ct. CaseBionix, LLCOGQ2022-10-27
00653160205695CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2022-01-01
10653160205692CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2022-01-01
00653160022766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
00653160023602CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
00653160024166CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
50653160022761CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
50653160023607CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
50653160024161CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOGQ2021-12-31
00031046605065Ezy Dose Self-CareAPOTHECARY PRODUCTS, LLCOGQ2021-03-26
20031046605069Ezy Dose Self-CareAPOTHECARY PRODUCTS, LLCOGQ2021-03-26
M572HBS033C114011Conformis Hip SystemConformis, Inc.OGQ2019-12-12
00783349000015Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31
00783349000077Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31
00783349000114Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31
00783349000299Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31
00783349000374Doctor Easy Medical ProductsDOCTOR EASY MEDICAL PRODUCTS, LLCOGQ2019-07-31