DEVICE: Blood Collection Needle without Needle Holder (06958697621623)
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Device Identifier (DI) Information
Blood Collection Needle without Needle Holder
18G × 1 1/2" TWLB
In Commercial Distribution
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
18G × 1 1/2" TWLB
In Commercial Distribution
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Blood Collection Needle without Needle Holder 18G × 1 1/2" TWLB
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 35209 | Non-fixed blood collection needle |
A 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 does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). 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 and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| FMI | Needle, Hypodermic, Single Lumen |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K223323 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
ba123c70-0131-45b9-8632-c40c184ef519
April 03, 2026
1
March 26, 2026
April 03, 2026
1
March 26, 2026
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 16958697621620 | 5400 | 06958697621623 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
26958697621627
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined