DEVICE: Closed Circuit Foley Catheter Tray (00100121850192)
Device Identifier (DI) Information
Closed Circuit Foley Catheter Tray
8501
In Commercial Distribution
Medical Shipment, LLC
8501
In Commercial Distribution
Medical Shipment, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
61355 | Urethral catheterization support kit, urinary drainage |
A collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OHR | Catheter Care Tray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6410943a-76f7-45dc-89a6-19e535a873dd
August 29, 2023
5
February 01, 2017
August 29, 2023
5
February 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00100121850185
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined