DEVICE: NA (00858778006409)
Device Identifier (DI) Information
NA
P1UVC-540
In Commercial Distribution
FOOTPRINT MEDICAL, INC.
P1UVC-540
In Commercial Distribution
FOOTPRINT MEDICAL, INC.
5.0Fr Single Lumen Polyurethane Umbilical 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? |
---|---|---|---|---|
10759 | Umbilical catheter |
A very thin flexible tube designed for umbilical blood vessel access in neonates, typically for the infusion of fluids. It is used mainly in arterial catheterization procedures, but venous catheterization is also possible. It will typically have a double or triple lumen to enable additional concurrent functions such as vital sign monitoring and blood sampling (e.g., for blood gas analysis). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FOS | Catheter, Umbilical Artery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K120304 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 5.0 French |
Device Record Status
54d1f669-9932-4606-a5e1-fba082dec765
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 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 |
---|---|---|---|---|---|
10858778006406 | 5 | 00858778006409 | In Commercial Distribution | Carton |
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
[?]
2102262600
info@footprintmed.com
info@footprintmed.com