DEVICE: Unifine Pentips - 4mm x 33G (00384700560010)

Device Identifier (DI) Information

Unifine Pentips - 4mm x 33G
AN0560SB10
In Commercial Distribution
AN0560SB10
OWEN MUMFORD USA INCORPORATED
00384700560010
GS1

10
803401454 *Terms of Use
For use with injectors for the subcutaneous injection of approved drugs, including insulin
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Autoinjector needle A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FMI Needle, Hypodermic, Single Lumen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152339 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 4 Millimeter
Needle Gauge: 33 Gauge
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Device Record Status

7a545d15-5882-4f5a-a74c-098824f171b3
July 06, 2018
3
September 19, 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
00384700560034 100 00384700560010 In Commercial Distribution Case
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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

[?]
Unit of Use DI Number: 00384700560000 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
770-977-2226
info@owenmumfordinc.com
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