DEVICE: IMPROVACUTER® Blood Collection Set with Pre-Attached Holder (06933395621045)
Device Identifier (DI) Information
IMPROVACUTER® Blood Collection Set with Pre-Attached Holder
21G x 3/4” x 12”
In Commercial Distribution
Guangzhou Improve Medical Instruments Co., Ltd.
21G x 3/4” x 12”
In Commercial Distribution
Guangzhou Improve Medical Instruments Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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 | 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 [?] |
---|---|
K153388 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d0d0ec6e-c477-411b-8e4a-79d90384cae1
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 |
---|---|---|---|---|---|
56933395621040 | 4 | 16933395621042 | In Commercial Distribution | ||
16933395621042 | 50 | 06933395621045 | In Commercial Distribution | ||
46933395621043 | 10 | 16933395621042 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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