DEVICE: IMPROSAFE® Multi Sample Needle (Flashback) (06933395620864)
Device Identifier (DI) Information
IMPROSAFE® Multi Sample Needle (Flashback)
22G × 1″
In Commercial Distribution
Guangzhou Improve Medical Instruments Co., Ltd.
22G × 1″
In Commercial Distribution
Guangzhou Improve Medical Instruments Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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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 | 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. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMI | Needle, Hypodermic, Single Lumen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K153388 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9592e3a3-fa22-4904-b161-0c931d7da34e
January 08, 2019
4
December 23, 2016
January 08, 2019
4
December 23, 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 |
---|---|---|---|---|---|
56933395620869 | 4 | 16933395620861 | In Commercial Distribution | ||
16933395620861 | 50 | 06933395620864 | In Commercial Distribution | ||
46933395620862 | 10 | 16933395620861 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined