DEVICE: Unistik ShieldLock (00384707522011)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
Unistik ShieldLock
WS 7522
In Commercial Distribution
OWEN MUMFORD USA INCORPORATED
WS 7522
In Commercial Distribution
OWEN MUMFORD USA INCORPORATED
Unistik ShieldLock 25G Safety Winged Set w/ Luer and Holder 12" tubing
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive |
A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. 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 [?] |
|---|---|
| K223854 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
ec265e53-6423-4836-893f-a9f7e2f16fbe
October 16, 2023
1
October 06, 2023
October 16, 2023
1
October 06, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 00384707522035 | 1000 | 00384707522011 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
00384707522004
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined