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.
AN 3850AH
In Commercial Distribution
AN 3850AH
Ahold U.S.A., Inc.
For use with injectors for the subcutaneous injection of approved drugs, including insulin
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No |
GMDN
[?]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? |
---|---|---|---|---|
44127 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMI | Needle, Hypodermic, Single Lumen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152339 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Needle Gauge: 31 Gauge |
Length: 5 Millimeter |
Device Record Status
6cf23e6d-a4d6-48ee-b10a-800484f5656b
July 06, 2018
3
September 19, 2016
July 06, 2018
3
September 19, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00384703850009
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
717-245-7474
xx@xx.xx
xx@xx.xx