DEVICE: Henry Schein (00304040016817)

Device Identifier (DI) Information

Henry Schein
1127097
In Commercial Distribution
1127097
HENRY SCHEIN, INC.
00304040016817
GS1

100
012430880 *Terms of Use
Needle Blunt Fill
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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
Medicine preparation needle/cannula, sterile A sterile slender metallic or plastic tube with a blunt distal end intended to be attached to a syringe in order to aspirate pharmaceutical fluids from vials or ampules during the preparation of some medications performed by healthcare professionals (e.g., pharmacists, physicians, nurses). This device is not intended for skin injections or tissue manipulation. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
LHI Set, i.V. Fluid transfer
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FDA Premarket Submission

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

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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

6315baf2-5e3c-444c-8399-95a1a91af8bb
March 29, 2018
2
September 24, 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
10304040016814 10 00304040016817 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: 20304040016811 CLOSE

Direct Marking (DM)

[?]
Yes
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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