DEVICE: DVT-SERIES (08809315675475)

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Device Record History
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Device Identifier (DI) Information
DVT-SERIES
DS021
In Commercial Distribution

DAESUNG MAREF CO.,LTD.
08809315675475
GS1

1
688817949 *Terms of Use
NON-WOVEN CALF SLEEVE Small 2ea, [One polybag]
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Device Characteristics
Labeling does not contain MRI Safety Information
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?
44768 Multi-chamber venous compression system garment, reusable
An inflatable device in the form of a stocking, sleeve, or suit that is 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 reusable 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 [?]
K203016 000
K203417 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
ccbebf73-99f0-4ebe-a3e8-99878c971b66
June 29, 2021
1
June 21, 2021
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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
18809315675472 10 08809315675475 In Commercial Distribution Box
28809315675479 20 08809315675475 In Commercial Distribution Box
38809315675476 40 08809315675475 In Commercial Distribution Box
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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

[?]
Yes
No
No
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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