DEVICE: V-Cath (B339380780)
Device Identifier (DI) Information
V-Cath
380-78
In Commercial Distribution
380-78
NEO MEDICAL INC.
380-78
In Commercial Distribution
380-78
NEO MEDICAL INC.
4.0Fr x 20cm Single Lumen Midline with Stylet and OTN Introducer
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
64573 | Peripheral intravenous catheterization kit |
A collection of devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. 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 [?] |
---|---|
K983916 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep Away From Sunlight |
Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 20.0 Centimeter |
Catheter Gauge: 4.0 French |
Device Record Status
b183f230-9aa6-4a8a-a18e-ed857747e491
August 02, 2023
4
September 24, 2016
August 02, 2023
4
September 24, 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 |
---|---|---|---|---|---|
B339380785 | 10 | B339380780 | 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
[?]
888-450-3334
support@neomedicalinc.com
support@neomedicalinc.com