CADD-Solis 21-2120-0102-51

GUDID 10610586042829

SMITHS MEDICAL MD, INC.

Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

• Primary Device ID: 10610586042829
• NIH Device Record Key: 8cb11118-5cc6-4ca0-a56a-0523c4f37029
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CADD-Solis
• Version Model Number: 2120
• Catalog Number: 21-2120-0102-51
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10610586042829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111275

FDA Product Code

• FRN: Pump, infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-06-17
• Device Publish Date: 2017-03-23

Devices Manufactured by SMITHS MEDICAL MD, INC.

• 10610586016981 - CADD: 2023-04-04
• 10610586016998 - CADD: 2023-04-04
• 10610586017018 - CADD: 2023-04-04
• 10610586043628 - CADD: 2023-04-04
• 30610586043325 - Level 1: 2022-11-28
• 30610586043332 - Level 1: 2022-11-28
• 30610586043349 - Level 1: 2022-11-28
• 30610586043356 - Level 1: 2022-11-28