DEVICE: Curaplex (00812277031546)

Device Identifier (DI) Information

Curaplex
1432-56000
In Commercial Distribution
1432-56000
BOUND TREE MEDICAL, LLC
00812277031546
GS1

1
070556204 *Terms of Use
Curaplex Hot Pack - Small - 5" x 5"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
13755 Mechanical external stethoscope
A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable 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
Special Storage Condition, Specify: protect device from freezing
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Width: 5 Inch
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Device Record Status

bd13d998-e35c-41d8-9180-c50c592d0540
November 25, 2024
2
December 15, 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
00812277031553 50 00812277031546 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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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