DEVICE: KMC Medical Balloon Catheter Syringe Pump (06938695540010)
Device Identifier (DI) Information
KMC Medical Balloon Catheter Syringe Pump
FG4001
In Commercial Distribution
Shanghai Kinetic Medical Co., Ltd.
FG4001
In Commercial Distribution
Shanghai Kinetic Medical Co., Ltd.
KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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17541 | Catheter/overtube balloon inflator, single-use |
A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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NDN | Cement, Bone, Vertebroplasty |
HRX | Arthroscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K113742 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: less than 80 Percent (%) Relative Humidity |
Handling Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 30 Centimeter |
Pressure: 440 Pound per Square Inch |
Device Record Status
f9966ab8-cce6-4c8a-8412-22cd38d012c0
May 06, 2020
2
January 06, 2020
May 06, 2020
2
January 06, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined