DEVICE: NeoMagic (B339194316250)
Device Identifier (DI) Information
NeoMagic
1943-1625
In Commercial Distribution
1943-1625
NEO MEDICAL INC.
1943-1625
In Commercial Distribution
1943-1625
NEO MEDICAL INC.
1.9Fr x 25cm, Single Lumen PICC with Stylet
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Peripherally-inserted central venous catheter | A sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LJS | Catheter,Intravascular,Therapeutic,Long-Term Greater 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 |
---|
Special Storage Condition, Specify: Keep Dry |
Special Storage Condition, Specify: Keep Away From Sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 25 Centimeter |
Catheter Gauge: 1.9 French |
Device Record Status
dc556c36-33f0-4639-84bf-0530f629c36e
March 29, 2018
2
September 24, 2016
March 29, 2018
2
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 |
---|---|---|---|---|---|
B339194316255 | 10 | B339194316250 | 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