DEVICE: NOVAPLUS (10192253061451)

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Device Record History
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Device Identifier (DI) Information
NOVAPLUS
V11440-512
In Commercial Distribution
V11440-512
Cardinal Health 200, LLC
10192253061451
GS1

1
961027315 *Terms of Use
Novaplus Cold Pack Instant Non-Sweat
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
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?
40555 Hot/cold therapy pack, single-use
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, peat) 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 single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IMD PACK, HOT OR COLD, DISPOSABLE
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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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Height: 9 Inch
Width: 4.5 Inch
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Device Record Status
6cb87f66-39e2-4c0e-86b0-2b00a29ede97
May 08, 2024
3
February 21, 2023
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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
20192253061458 12 10192253061451 In Commercial Distribution BOX
50192253061459 4 20192253061458 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

[?]
No Customer Contact currently defined
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