ACIST HDi® Bed Rail Mount

GUDID 30841716100773

HDi Bed Rail Mount, p/n 701575-001

ACIST MEDICAL SYSTEMS, INC.

Cardiovascular ultrasound imaging system

• Primary Device ID: 30841716100773
• NIH Device Record Key: 2fb16e86-2b74-45e2-8370-6e0428e6706e
• Commercial Distribution Discontinuation: 2020-01-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACIST HDi® Bed Rail Mount
• Version Model Number: 018196
• Company DUNS: 926684994
• Company Name: ACIST MEDICAL SYSTEMS, 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: true
• Serial Number: false
• 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	10841716100779 [Primary]
GS1	30841716100773 [Package]; Contains: 10841716100779; Package: Shelf box [1 Units]; Discontinued: 2020-01-14; Not in Commercial Distribution

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-04-22
• Device Publish Date: 2016-09-09

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

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• 30841716103514 - ACIST HDi® System Console: 2024-11-21 HDi System Console
• 30841716103521 - ACIST HDi® Power Supply: 2024-11-21 HDi Power Supply
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• 20841716100004 - ACIST Navvus® Catheter: 2024-06-12 Navvus Catheter, p/n 701481-002
• 10841716100014 - ACIST Navvus® Catheter: 2024-06-12 Navvus Catheter, p/n 701481-003