MIO

GUDID 00850042929179

Mio Lancing Device

Mio Labs Inc.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable
Primary Device ID00850042929179
NIH Device Record Keyc3960407-7ac7-4314-8523-c789594efd12
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIO
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
GS100850042929179 [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 Date2023-09-11
Device Publish Date2023-09-01

On-Brand Devices [MIO]

00850042929070GBS-2104-G
00850042929049Mio Lancing Device
00850042929032Mio Single Use Lancets
00850042929025Mio Control Solution
00850042929018Blood Glucose Test Strip
00850042929001Blood Glucose Meter
00850042929148Mio Blood Glucose Test Strip
00850042929131Mio Blood Glucose Meter
10850042929169Mio Single Use Lancets
00850042929179Mio Lancing Device
00850042929162Mio Single Use Lancets
00850042929155Mio Control Solution
00850042929186MIO Blood Glucose Monitoring System

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