DEVICE: Rapr-Round (07613327175103)
Device Identifier (DI) Information
Rapr-Round
8001-061-535
In Commercial Distribution
8001-061-535
STRYKER CORPORATION
8001-061-535
In Commercial Distribution
8001-061-535
STRYKER CORPORATION
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
36854 | External circulating-fluid core temperature regulation system pad, reusable |
An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWJ | System, thermal regulating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K100585 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -40 and 140 Degrees Fahrenheit |
Handling Environment Temperature: between -40 and 140 Degrees Fahrenheit |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bc973f63-0031-4c36-8888-5802894ae33b
December 18, 2023
4
September 24, 2016
December 18, 2023
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
57613327175108 | 5 | 07613327175103 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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