DEVICE: KMC Medical Balloon Catheter Syringe Pump (06938695540058)
Device Identifier (DI) Information
KMC Medical Balloon Catheter Syringe Pump
FG4003
In Commercial Distribution
FG4003
Shanghai Kinetic Medical Co., Ltd.
FG4003
In Commercial Distribution
FG4003
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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRX | Arthroscope |
NDN | Cement, Bone, Vertebroplasty |
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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Storage Environment Humidity: less than 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Pressure: 440 Pound per Square Inch |
Length: 60 Centimeter |
Device Record Status
6dfd7a4e-fe76-431f-bd8a-694922da45f1
May 06, 2020
5
May 18, 2016
May 06, 2020
5
May 18, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+862150720558
qingmeiwei@kineticmedinc.com
qingmeiwei@kineticmedinc.com