CareLiving MM1100 Blood Glucose Test Strips 100ct 83568-1007-34

GUDID 10383568100731

Blood Glucose Test Strips,50ct/box,two box, for use with blood glucose monitoring system

Care Living Diagnostics Inc.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

Primary Device ID	10383568100731
NIH Device Record Key	4527587b-edb8-4a98-8c0e-dca07f234d62
Commercial Distribution Status	In Commercial Distribution
Brand Name	CareLiving MM1100 Blood Glucose Test Strips 100ct
Version Model Number	MM1100-100ct
Catalog Number	83568-1007-34
Company DUNS	125354643
Company Name	Care Living Diagnostics Inc.
Device Count	100
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383568100734 [Primary]
GS1	10383568100731 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K111456

FDA Product Code

CGA	Glucose Oxidase, Glucose

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-04-29
Device Publish Date	2024-04-19

Devices Manufactured by Care Living Diagnostics Inc.

00383568100727 - CareLiving MM1100 Blood Glucose Meter	2024-04-29 CareLiving MM1100 Meter
10383568100731 - CareLiving MM1100 Blood Glucose Test Strips 100ct	2024-04-29Blood Glucose Test Strips,50ct/box,two box, for use with blood glucose monitoring system
10383568100731 - CareLiving MM1100 Blood Glucose Test Strips 100ct	2024-04-29 Blood Glucose Test Strips,50ct/box,two box, for use with blood glucose monitoring system
10383568100748 - CareLiving MM1100 Blood Glucose Test Strips 50ct	2024-04-29 Blood Glucose Test Strips,2 bottles of 25 strips in one 50 strip box, for use with blood glucose monitoring system
00383568100758 - CareLiving MM1100 Control Solution For Blood Glucose	2024-04-29 CareLiving MM1100 Control Solution
00383568100413 - CareLiving Lancing Device	2024-04-18 With12 customizable depth settings, Compact design, highly portable and easy to use, helps to achieve tiny stings on the skin.Th
00383568100420 - CareLiving Lancing Device+100 Lancets	2024-04-18 1 x CARELIVING Lancing device, 100 x 30 Gauge Lancets.1 x User Guide,LESS PAINFUL,STRONG PENETRATION,12 OPTIONAL DEPTH SETTINGS,
10383568100342 - CareLiving Blood Lancet 30G 50pcs Blue Color	2024-04-16 • 30 Gauge • Blue Color•Twist top lancets • Single use • Provides virtually painless testing • Comfort depth penetra
10383568100236 - CareLiving Push Button Activated Safety lancet 28G	2024-02-02 Push Button Activated Safety lancet 28G*1.6mm,100pcs Per Box,Sterile Singel-use,No need pre-loading,High speed of penetration an