DEVICE: K-Pack II (05413206003792)

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Device Identifier (DI) Information

K-Pack II
KN-2325RB
KN-2325RB
Terumo Europe NV
05413206003792
GS1
1
K-Pack II Needle
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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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Hypodermic needle, single-use, sterile A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes, secondary medication sets, or phlebotomy equipment (e.g., blood collection adapters or holders) to prepare and administer fluids/medications/drugs to a patient and/or to withdraw(aspirate) fluids from a patient. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FMI Needle, Hypodermic, Single Lumen
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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
Special Storage Condition, Specify: Do not store at extreme temperature and humidity.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Needle Length: 1 Inch
Needle Gauge: 23 Gauge
Device Size Text, specify: Needle Length: 25 Millimeter
Device Size Text, specify: Needle Outer Diameter: 0.6 Millimeter
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Device Status

In Commercial Distribution
September 05, 2016

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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
55413206003797 5000 05413206003792 In Commercial Distribution Carton
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
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