DEVICE: Thumper (00860682000107)

Device Identifier (DI) Information

Thumper
1007CCMII
In Commercial Distribution
15350
MICHIGAN INSTRUMENTS, LLC
00860682000107
GS1

1
081208064 *Terms of Use
External Cardiac Compressor - Model 1007CCMII
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Device Characteristics

MR Safe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45748 Cardiac resuscitator, pneumatic
A pneumatically-powered external device designed for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. It is typically powered from medical gas cylinders or a medical gas pipeline system and may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRM Compressor, Cardiac, External
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K972525 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

863ba9a8-47b4-44f5-ba59-1f37b4d34894
July 11, 2023
5
September 12, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
616-554-9696
mii@michinst.com
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