DEVICE: CARDINAL HEALTH (10195594103118)
Device Identifier (DI) Information
CARDINAL HEALTH
SCVCGOHIL1
In Commercial Distribution
SCVCGOHIL1
Cardinal Health 200, LLC
SCVCGOHIL1
In Commercial Distribution
SCVCGOHIL1
Cardinal Health 200, LLC
OPEN HEART PACK B ILM
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
61371 | Cardiothoracic surgical procedure kit, non-medicated, single-use |
A collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OEZ | Cardiovascular procedure kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4e341fdd-fb9a-40d0-a704-35b37e7fdaa9
June 02, 2021
1
May 25, 2021
June 02, 2021
1
May 25, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50195594103116 | 1 | 10195594103118 | 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