Eitan Medical AAA-00171

GUDID 00862492000353

OPTUMHEALTH CARE SOLUTIONS, INC.

Bedside infusion pump, single-channel

• Primary Device ID: 00862492000353
• NIH Device Record Key: f944a90d-91cd-4eac-8463-dc0f45d248ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eitan Medical
• Version Model Number: Pump Avoset Infusion
• Catalog Number: AAA-00171
• Company DUNS: 078270206
• Company Name: OPTUMHEALTH CARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862492000353 [Primary]

FDA Product Code

• FRN: Pump, infusion

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: 2024-05-02
• Device Publish Date: 2024-04-24

Devices Manufactured by OPTUMHEALTH CARE SOLUTIONS, INC.

• 00862492000353 - Eitan Medical: 2024-05-02
• 00862492000353 - Eitan Medical: 2024-05-02
• 00862492000308 - Zyno Solutions: 2020-12-15 Nimbus II-Optum Homecare Infusion
• 00862492000315 - Portal 724: 2020-12-15 Optum Home Scale I-Apollo
• 00862492000322 - Portal 724: 2020-12-15 Optum Home Scale I-ICUE
• 00862492000339 - A&D: 2020-12-15 Optum Home BP I-Apollo
• 00862492000346 - A&D: 2020-12-15 Optum Homecare Portal W/BP
• 08624920003082 - Omron: 2020-06-03 Optum Homecare LG W/BP
• 08624920003099 - CME: 2020-06-03 T34-Optum Homecare Infusion