Thumper 15350

GUDID 00860682000107

External Cardiac Compressor - Model 1007CC

MICHIGAN INSTRUMENTS, LLC

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