CareLiving MM1100 Control Solution For Blood Glucose 83568-1007-58

GUDID 00383568100758

CareLiving MM1100 Control Solution

Care Living Diagnostics Inc.

Glucose monitoring system IVD, home-use
Primary Device ID00383568100758
NIH Device Record Key1e638373-5407-4fd2-8372-c1258ca6a9f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareLiving MM1100 Control Solution For Blood Glucose
Version Model NumberMM1100
Catalog Number83568-1007-58
Company DUNS125354643
Company NameCare Living Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com
Phone1-888-811-9866
Emailservice@careliving.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100383568100758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-29
Device Publish Date2024-04-19

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