DEVICE: AUVON (06971292003526)
Device Identifier (DI) Information
AUVON
I
In Commercial Distribution
Shenzhen Yuwen E-Commerce Co., Ltd.
I
In Commercial Distribution
Shenzhen Yuwen E-Commerce Co., Ltd.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61579 | Blood lancet, single-use |
A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QRL | Multiple Use Blood Lancet For Single Patient Use Only |
QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
81150566-ef46-4f5d-b489-32f75a775ddd
April 18, 2025
1
April 10, 2025
April 18, 2025
1
April 10, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
16971292003523 | 80 | 06971292003526 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(678)829-7256
support@iauvon.com
support@iauvon.com