DEVICE: ROSC-U System (00860000876209)

Device Identifier (DI) Information

ROSC-U System
A03-01-000
In Commercial Distribution
A03-01-000
RESUSCITATION INTERNATIONAL, LLC
00860000876209
GS1

1
053006828 *Terms of Use
Mechanical CPR system, including Battery Control Unit, Compressor, Torso Restraints (10 pk), Torso Restraints XL (5 pk), Battery Charger
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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Yes
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GMDN

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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?
61908 Cardiac resuscitator, battery-powered
A battery-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 may be available in a variety of forms but includes a mechanical chest compressor (e.g., plunger-type), a battery-powered control unit, and patient straps/supports. The device is typically used as an adjunct to or substitute for manual external cardiac compression in cases where manual compression is not ideal, or to prevent fatigue and improve consistency (i.e., of force, rate).
Active false
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FDA Product Code

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Product Code Product Code Name
DRM Compressor, Cardiac, External
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b1212136-6466-469e-99f1-37487c856806
December 23, 2019
1
December 13, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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