CareLiving Lancing Device

FDA UDI

Class II (US FDA UDI)

by Care Living Diagnostics Inc

Identity

Trade Name: CareLiving Lancing Device FDA UDI
Generic Name: Manual blood lancing device, reusable FDA UDI
Device Name: With12 customizable depth settings, Compact design, highly portable and easy to use, helps to achieve tiny stings on the skin.The button device is quick and easy to use; the device captures enough blood to test on the diabetes monitor for accurate results. FDA UDI
Model / Reference: Lancing Device FDA UDI
Description: With12 customizable depth settings, Compact design, highly portable and easy to use, helps to achieve tiny stings on the skin.The button device is quick and easy to use; the device captures enough blood to test on the diabetes monitor for accurate results. FDA UDI

Identifiers

Catalog Number: 83568-1004-20 FDA UDI
Primary DI / UDI-DI: 00383568100420 FDA UDI
510(k) Number: K232330 FDA UDI
FDA Product Code: QRL FDA UDI
GMDN Term: Manual blood lancing device, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Manual blood lancing device, reusable

CareLiving Lancing Device by Care Living Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual blood lancing device, reusable.

Pylo Health — PREVOUNCE HEALTH, INC · Class II
Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
BEWELL CONNECT MyGluco Lancing device — Visiomed Group SA · Class II
Autolet — OWEN MUMFORD USA INCORPORATED · Class II
Lancing Device — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
TeleRPM & Chronica — Mio Labs Inc.
Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Care Living Diagnostics Inc

Sources (1)

FDA UDI b2ce588c-dc21-4dbe-9523-bffe9aa905be 35 fields · synced May 30, 2026