FDA.reportPublic FDA data

One Drop

Primary DI
00859509006118
Brand
One Drop
Company
INFORMED DATA SYSTEMS INC.
Model
8000-10556
Device description
Lancets, 33G, 100CT, Boxed, One Drop, US-UK
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRLMultiple Use Blood Lancet For Single Patient Use Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859509006118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859509006118008595090061188595090061180859509006118

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-437-1474customerservice@onedrop.today

Regulatory Flags#

DUNS number
079628966
Device count
1
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859509006057One Drop8300-105322023-01-06
00859509006026One Drop8000-104952017-04-07
00859509006064One Drop8000-105842017-10-01
00859509006019One Drop8000-104652017-04-07
10859509006023One Drop8000-104952017-04-07
20859509006068One Drop8000-105842017-10-01
00859509006033One Drop8000-105102017-04-07
20859509006051One Drop8000-105102017-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428167298TRUEdrawTRIVIDIA HEALTH, INC.QRL2026-08-14
00810011730755leraiseTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730779VivaGuardTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730786VivaGuardTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730793HuahongTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00194631000079Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-09
00194631000024Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000031Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000048Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000062Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00810011730700GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-11
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRL2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-06
00860015383952True IntegralTRUE INTEGRAL INCQRL2026-04-14
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
36945630142001STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
00850080988107AUVONUAN HEALTHCARE LIMITEDQRL2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRL2026-03-02
00810079240579Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRL2026-02-06
00682607541829On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
20682607541823On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
50810011730644HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730656HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730663AllevyTianjin Huahong Technology Co., Ltd.QRL2025-12-24
06949517009462N/MShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-12-10
00850065253305LIVE TULA Lancing DeviceTULA HEALTH, INC.QRL2025-12-03