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.
Catalog Number
-
Brand Name
AUVON
Version/Model Number
LD11000B1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
QRK
Product Code Name
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Public Device Record Key
bb2f8f91-0d9a-4bcb-afda-ad467e054aab
Public Version Date
October 26, 2022
Public Version Number
1
DI Record Publish Date
October 18, 2022
Package DI Number
16971292001567
Quantity per Package
150
Contains DI Package
06971292001560
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |