Health Wealth Safe

GUDID 00850042929360

Lancing Device

Mio Labs Inc.

Manual blood lancing device, reusable
Primary Device ID00850042929360
NIH Device Record Key71e092a4-5422-467e-9009-3e6f53b1bba3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth Wealth Safe
Version Model NumberHH-XIII-T
Company DUNS117119317
Company NameMio Labs Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042929360 [Primary]

FDA Product Code

QRLMultiple Use Blood Lancet For Single Patient Use Only

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-06
Device Publish Date2024-01-29

On-Brand Devices [Health Wealth Safe]

00850042929377TeleRPM Blood Glucose Monitoring System
00850042929360Lancing Device
00850042929353Single Use Lancets
00850042929346Control Solution
00850042929339Blood Glucose Test Strip
00850042929322TeleRPM Blood Glucose Meter

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