DEVICE: Curaplex (00812277031546)
Device Identifier (DI) Information
Curaplex
1432-56000
In Commercial Distribution
1432-56000
BOUND TREE MEDICAL, LLC
1432-56000
In Commercial Distribution
1432-56000
BOUND TREE MEDICAL, LLC
Curaplex Hot Pack - Small - 5" x 5"
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IMD | PACK, HOT OR COLD, DISPOSABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: protect device from freezing |
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 5 Inch |
Device Record Status
bd13d998-e35c-41d8-9180-c50c592d0540
November 25, 2024
2
December 15, 2018
November 25, 2024
2
December 15, 2018
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined