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.
06938695540010
GS1

1
528198569 *Terms of Use
KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
NDN Cement, Bone, Vertebroplasty
HRX Arthroscope
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113742 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Humidity: less than 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 30 Centimeter
Pressure: 440 Pound per Square Inch
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Device Record Status

f9966ab8-cce6-4c8a-8412-22cd38d012c0
May 06, 2020
2
January 06, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
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Customer Contact

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No Customer Contact currently defined
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