DEVICE: UMBILI-CATH (H67141735050)
Device Identifier (DI) Information
UMBILI-CATH
Single-Lumen Silicone
In Commercial Distribution
4173505
UTAH MEDICAL PRODUCTS, INC.
Single-Lumen Silicone
In Commercial Distribution
4173505
UTAH MEDICAL PRODUCTS, INC.
A Single-Lumen Silicone Umbilical Catheter, 3.5 French
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FOS | Catheter, Umbilical Artery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K940953 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 34 Centimeter |
Catheter Gauge: 3.5 French |
Device Record Status
7151626f-356a-4562-b59c-d15ad83228f0
December 18, 2019
4
September 23, 2016
December 18, 2019
4
September 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 |
---|---|---|---|---|---|
H67140735051 | 10 | H67141735050 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
800-533-4984
customer@utahmed.com
customer@utahmed.com