Elevate ArmBoard - Right Hand 180-0100-00-RH

GUDID 10815614020705

The Elevate ArmBoard Model 8100-RH slides under a patient mattress and integrates with the single-use mBrace Model 4250 wrist support device to support a patient's right arm during a cannulation procedure such as a catheterization into the radial artery.

SEMLER TECHNOLOGIES, INC.

Radiological arm/leg positioner

• Primary Device ID: 10815614020705
• NIH Device Record Key: f1751301-9dd5-4246-998e-607e916a9f06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elevate ArmBoard - Right Hand
• Version Model Number: 8100-RH
• Catalog Number: 180-0100-00-RH
• Company DUNS: 042075700
• Company Name: SEMLER TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815614020705 [Primary]

FDA Product Code

• FMQ: Restraint, Protective

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: 2022-11-25
• Device Publish Date: 2022-11-17

On-Brand Devices [Elevate ArmBoard - Right Hand]

• 10815614020927: The refurbished Elevate ArmBoard Model 8100-RH-U slides under a patient mattress and integrates
• 10815614020705: The Elevate ArmBoard Model 8100-RH slides under a patient mattress and integrates with the singl