DEVICE: Uni-Patch (10884527021376)

Device Identifier (DI) Information

Uni-Patch
MV75140
In Commercial Distribution
MV75140
Cardinal Health, Inc.
10884527021376
GS1

1
080935429 *Terms of Use
Compression Wrap with Gel Pack
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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?
37240 Hot/cold therapy pack, reusable
A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IME Pack, hot or cold, reusable
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: ;
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Clinically Relevant Size

[?]
Size Type Text
Width: 6 Inch
Length: 48 Inch
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Device Record Status

d6a6c16e-63d1-477c-b32a-9ec4ea2be2f1
February 15, 2019
2
June 30, 2018
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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
90884527021372 10 10884527021376 In Commercial Distribution CASE
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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
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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