Thumper 15350

GUDID 00860682000107

External Cardiac Compressor - Model 1007CC

MICHIGAN INSTRUMENTS, LLC

Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic Cardiac resuscitator, pneumatic

• Primary Device ID: 00860682000107
• NIH Device Record Key: 863ba9a8-47b4-44f5-ba59-1f37b4d34894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thumper
• Version Model Number: 1007CC
• Catalog Number: 15350
• Company DUNS: 081208064
• Company Name: MICHIGAN INSTRUMENTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com
• Phone: 616-554-9696
• Email: mii@michinst.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860682000107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851139
• Premarket Notification: K972525

FDA Product Code

• DRM: Compressor, Cardiac, External

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-18
• Device Publish Date: 2014-09-12

Devices Manufactured by MICHIGAN INSTRUMENTS, LLC

• 00860682000107 - Thumper: 2018-07-18External Cardiac Compressor - Model 1007CC
• 00860682000107 - Thumper: 2018-07-18 External Cardiac Compressor - Model 1007CC
• 00860682000114 - Michigan Instruments. Inc. Thumper: 2018-07-18 External Cardiac Compressor - Thumper Model 1007CCV
• 00860682000121 - Michigan Instruments, Inc. Life-Stat: 2018-07-18 External Cardiac Compressor - Life-Stat