DEVICE: 4 chamber sleeve (08809802640528)

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Device Record History
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Device Identifier (DI) Information
4 chamber sleeve
SXW401
In Commercial Distribution

DAESUNG MAREF CO.,LTD.
08809802640528
GS1

1
688817949 *Terms of Use
OVERLAPPING LEG SLEEVE Small X-Wide 1ea [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?
10969 Intermittent venous compression system
A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.
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 [?]
K150033 000
K203019 000
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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

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Size Type Text
No Device Sizes
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Device Record Status
9a4ca57f-4502-48d9-9db1-d2aa8df0bea4
April 20, 2023
2
December 17, 2021
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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
18809802640525 4 08809802640528 In Commercial Distribution Box
28809802640522 6 08809802640528 In Commercial Distribution Box
38809802640529 20 08809802640528 In Commercial Distribution Box
48809802640526 25 08809802640528 In Commercial Distribution Box
58809802640523 10 08809802640528 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: 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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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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