AUVON - The RightLance Blood Lancing System is intended - Shenzhen Yuwen E-Commerce Co., Ltd.

Duns Number:544559614

Device Description: The RightLance Blood Lancing System is intended for the hygienic collection of capillary b The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

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More Product Details

Catalog Number

-

Brand Name

AUVON

Version/Model Number

LD33000P1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

QRK

Product Code Name

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Device Record Status

Public Device Record Key

a1f502e0-127d-452c-81cd-ef2a15973709

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Additional Identifiers

Package DI Number

16971292001475

Quantity per Package

80

Contains DI Package

06971292001478

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SHENZHEN YUWEN E-COMMERCE CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 99