CareLiving Lancing Device 83568-1004-13

GUDID 00383568100413

With12 customizable depth settings, Compact design, highly portable and easy to use, helps to achieve tiny stings on the skin.The button device is quick and easy to use; the device captures enough blood to test on the diabetes monitor for accurate results.

Care Living Diagnostics Inc.

Manual blood lancing device, reusable

• Primary Device ID: 00383568100413
• NIH Device Record Key: f2c82c78-4f96-430a-b85b-3e6336d9e818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareLiving Lancing Device
• Version Model Number: Lancing Device
• Catalog Number: 83568-1004-13
• Company DUNS: 125354643
• Company Name: Care Living Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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	00383568100413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232330

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-18
• Device Publish Date: 2024-04-10

Devices Manufactured by Care Living Diagnostics Inc.

• 00383568100826 - CareLiving BGM101 Blood Glucose Meter: 2024-08-15 CareLiving BGM101 Meter
• 00383568100802 - CareLiving Blood Glucose Monitor Kit: 2024-07-24 BLOOD GLUCOSE MONITOR KIT CareLiving BGM101 Meter CareLiving BGM101 100 x Test Strips CareLiving Lancing Device CareLiving 100 x
• 10383568100243 - CareLiving Pressure Activated Safety lancet 26G: 2024-07-04 Pressure Activated Safety lancet 26G*1.8mm,100pcs Per Box,Sterile Singel-use,No need pre-loading,High speed of penetration and l
• 10383568100205 - CareLiving Pressure Activated Safety lancet 21G: 2024-07-01 Pressure Activated Safety lancet 21G*1.8mm,100pcs Per Box,Sterile Singel-use,No need pre-loading,High speed of penetration and l
• 00383568100727 - CareLiving MM1100 Blood Glucose Meter: 2024-04-29 CareLiving MM1100 Meter
• 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