DEVICE: Vive (00810113570716)

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Device Record History
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Device Identifier (DI) Information
Vive
RHB2098BLK
In Commercial Distribution

VIVE HEALTH LLC
00810113570716
GS1

1
047025993 *Terms of Use
Arm Compression Pump (Full System) Premium
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
47888 Portable sequential venous compression system
A compact portable system designed for the noninvasive treatment and prevention of venous disorders and sequelae (lymphatic, arterial, trauma) by facilitating better vascular flow, as well as minimizing venous stasis during/after surgery and immobilization. It applies sequential pressure to a patient's arm or leg to promote venous blood flow and typically consists of an electrically-powered compression pump, control/timing mechanism, rechargeable batteries, and tubing that connect to an integral cuff or pneumatic stockings that inflate and deflate sequentially. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized/institutionalized patients.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IRP Massager, Powered Inflatable Tube
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K192358 000
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Sterilization
No
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
fe275e49-c9fd-4b17-a264-da3fd88f914b
July 03, 2023
1
June 23, 2023
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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
10810113570713 2 00810113570716 In Commercial Distribution Case
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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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Yes
No
None
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Production Identifier(s) in UDI

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No
No
No
No
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Customer Contact

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No Customer Contact currently defined
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