DEVICE: PowerStick (B3394010116100)

Device Identifier (DI) Information

PowerStick
40101-1610
In Commercial Distribution
40101-1610
NEO MEDICAL INC.
B3394010116100
HIBCC

1
015510540 *Terms of Use
PowerStick 18ga x 10cm, Power Rated EPIV with MST
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Peripheral vascular catheter A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
LJS Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K071875 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Away From Sunlight
Special Storage Condition, Specify: Keep Dry
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Clinically Relevant Size

[?]
Size Type Text
Pressure: 300 Pound per Square Inch
Length: 10.0 Centimeter
Catheter Gauge: 4.0 French
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Device Record Status

9080b16e-529e-4b1e-ac84-459ffd89cc2a
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B3394010116105 10 B3394010116100 In Commercial Distribution Case
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
888-450-3334
support@neomedicalinc.com
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