Alpine BioMed

GUDID 05704736017121

"Keypoint Focus Notebook System, Intl. 230V ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integra

Alpine Biomed ApS

Electromyograph

• Primary Device ID: 05704736017121
• NIH Device Record Key: f49acffe-296b-4beb-8a00-da7c27a6c977
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpine BioMed
• Version Model Number: 9033A071101
• Company DUNS: 311231554
• Company Name: Alpine Biomed ApS
• 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	05704736017121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944547

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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: 2018-07-06
• Device Publish Date: 2016-08-24

On-Brand Devices [Alpine BioMed]

• 00613994242297: KEYPOINT WS UKXP-OS
• 00613994197580: Clavis EMG/ Stim Device
• 00681490920704: EP Headbox incl. 1.5m Cable
• 00681490920674: 8-channel EMG/EP Amplifier with 1.7 m cable
• 00681490920667: 4 ch Amp- EMG/EP Amplifier with 1.7 m cable
• 00681490920650: 2-channel EMG/EP Amplifier with 1.7 m cable
• 00681490853149: 4 CH EP ADC BOARD FOR KEYPOINT
• 00681490508865: 4 CH. AMP.BOX/ARM, KEYPOINT
• 00673978875644: MULTI STIM, 2 M CABLE
• 00673978212043: ACTIVE HANDGRIP FOR KP G3
• 00673978206998: 4 CH. AMP BOX/ARM KEYPOINT
• 00673978206981: 2 CHANNEL EMG/EP AMPLI-
• 00721902796227: 5CH. PREAMPL. BOX. FOR LEAD- POINT
• 00721902565236: SINGLE CONSTANT CURRENT STIMULATOR, CABLE 0.85 M
• 00721902428531: EP HEADBOX UNIT
• 00721902428524: 8 CH. AMPLIFIER
• 00721902428517: 4 CH. AMPLIFIER
• 00721902428500: 2 CH. AMPLIFIER
• 00885074326702: EP Headbox incl. 1.5m Cable
• 00885074326696: 8-channel EMG/EP Amplifier with 1.7 m cable
• 00885074322919: 4 ch Amp- EMG/EP Amplifier with 1.7 m cable
• 00885074322889: 2-channel EMG/EP Amplifier with 1.7 m cable
• 00885074292014: LEADPOINT WORKSTATION 5+3, US
• 00885074292007: LEADPOINT WORKSTATION 5+3, IT
• 00885074291741: LEADPOINT WORKSTATION 5+3, NL
• 00885074291734: LEADPOINT WORKSTATION 5+3, SP
• 00885074291710: LEADPOINT WORKSTATION 5+3, GE
• 00885074291697: LEADPOINT WORKSTATION 5+3, FR
• 00885074291673: LEADPOINT WORKSTATION 5+3, UK
• 00885074291635: G3 KEYPOINT WORKSTATION US
• 00885074291611: KEYPOINT WORKST IT
• 00885074291598: KEYPOINT WORKST NL
• 00885074291574: KEYPOINT WORKST SP
• 00885074291567: G3 KEYPOINT WORKSTATION GE
• 00885074291529: KEYPOINT WORKST FR
• 00885074291499: KEYPOINT WORKST UK
• 05704736019859: FOCUS MAIN UNIT
• 05704736019477: "Keypoint Focus Module: CN Including: - Keypoint Focus main unit with control panel, integrated
• 05704736019408: Macro Stimulator
• 05704736019330: ACTIVE HANDGRIP FOR KP G3
• 05704736019200: Notebook kit, Focus
• 05704736019170: Cable kit for Focus Main Unit
• 05704736019163: KP FOCUS PC SYSTEM, UK 230V SPECIAL LABELING FOR CHINA
• 05704736019156: Keypoint G4, CHINA
• 05704736019149: KP Focus Notebook, UK 230V special for China
• 05704736019064: FRONT END BOX, KEYPOINT G4
• 05704736019026: FOCUS MAIN UNIT
• 05704736018890: LP Focus Workst. system, E
• 05704736018883: LP Focus Workst. system, G
• 05704736018876: LP Focus Workst. system, F