DEVICE: Albahealth (00073614789128)

Device Identifier (DI) Information

Albahealth
000753062100931
In Commercial Distribution

Albahealth, LLC
00073614789128
GS1

1
003375805 *Terms of Use
3X LARGE-REGULAR KNEE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Compression sock/stocking, single-use A tube-like garment made of elastic material (e.g., circular knit nylon and Spandex yarns) that exerts a pressure across the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation [e.g., oedema, deep vein thrombosis (DVT), varicosis]. It may be intended to apply a graduated pressure across a limb, however it is not intended to support an injured joint. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DWL Stocking, medical support (to prevent pooling of blood in legs)
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FDA Premarket Submission

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

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Size Type Text
No Device Sizes
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Device Record Status

1b3854e6-43b0-45ea-be72-25b0a9ea3d93
March 29, 2018
2
September 23, 2016
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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
50073614789123 12 00073614789128 In Commercial Distribution
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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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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