DEVICE: The Venous Assist System(DVT-2600) (08809315678759)

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Device Record History
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Device Identifier (DI) Information
The Venous Assist System(DVT-2600)
DS241
In Commercial Distribution

DAESUNG MAREF CO.,LTD.
08809315678759
GS1

2
688817949 *Terms of Use
3chamber soft fabric boots garment (One size)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
44762 Multi-chamber venous compression system garment, single-use
A non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JOW Sleeve, Limb, Compressible
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K112677 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
e3567e16-006a-43cc-b563-6d25bf2ac2fc
June 24, 2021
4
October 18, 2016
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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
38809315678750 4 18809315678756 In Commercial Distribution BOX
18809315678756 10 08809315678759 In Commercial Distribution BOX
28809315678753 2 18809315678756 In Commercial Distribution BOX
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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: 08809315678742 CLOSE

Direct Marking (DM)

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

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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