DEVICE: Jelco (00351688060481)

Device Identifier (DI) Information

Jelco
972506
In Commercial Distribution

SMITHS MEDICAL ASD, INC.
00351688060481
GS1

1
137835299 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
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
Blood collection needle, basic A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. 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 [?]
K895705 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5a040832-907a-4813-a3b7-0065e704a77e
July 06, 2018
3
January 12, 2017
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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
10351688060488 50 00351688060481 In Commercial Distribution BOX
30351688060482 4 10351688060488 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: 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

[?]
No Customer Contact currently defined
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