Elevate ArmBoard - Left Hand 180-0100-00-LH-U

GUDID 10815614020910

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

SEMLER TECHNOLOGIES, INC.

Radiological arm/leg positioner
Primary Device ID10815614020910
NIH Device Record Key6fbd9092-5244-4d97-a33d-a6a2a68b5bff
Commercial Distribution StatusIn Commercial Distribution
Brand NameElevate ArmBoard - Left Hand
Version Model Number8100-LH-U
Catalog Number180-0100-00-LH-U
Company DUNS042075700
Company NameSEMLER TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110815614020910 [Primary]

FDA Product Code

FMQRestraint, Protective

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-25
Device Publish Date2022-11-17

On-Brand Devices [Elevate ArmBoard - Left Hand]

10815614020910The refurbished Elevate ArmBoard Model 8100-LH-U slides under a patient mattress and integrates
10815614020699The Elevate ArmBoard Model 8100-LH slides under a patient mattress and integrates with the singl

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