DEVICE: WOLF-PAK Self Safe Safety IV Catheter (08032248371873)
Device Identifier (DI) Information
WOLF-PAK Self Safe Safety IV Catheter
3718760
In Commercial Distribution
DELTA MED SPA
3718760
In Commercial Distribution
DELTA MED SPA
IV safety catheter
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 64574 | Peripheral intravenous cannula |
A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Length: 19 Millimeter |
| Device Size Text, specify: GAUGE 24 |
| Outer Diameter: 0.74 Millimeter |
Device Record Status
fb604f03-1754-488f-9448-435525bdf400
January 28, 2020
1
January 20, 2020
January 28, 2020
1
January 20, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 58032248371878 | 4 | 38032248371874 | In Commercial Distribution | box | |
| 38032248371874 | 50 | 08032248371873 | In Commercial Distribution | case |
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