DEVICE: Ahold - CareOne UPP 5mm pen needles (00041520035363)

Device Identifier (DI) Information

Ahold - CareOne UPP 5mm pen needles
AN 3850AH
In Commercial Distribution
AN 3850AH
Ahold U.S.A., Inc.
00041520035363
GS1

100
170199058 *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
Yes
Yes
Yes
Yes
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
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

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

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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

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Size Type Text
Needle Gauge: 31 Gauge
Length: 5 Millimeter
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Device Record Status

6cf23e6d-a4d6-48ee-b10a-800484f5656b
March 29, 2018
2
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
00041520090898 6 00041520035363 In Commercial Distribution Sleeve
10041520090895 24 00041520090898 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

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Unit of Use DI Number: 00384703850009 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
717-245-7474
xx@xx.xx
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