DEVICE: DuraFlow (H787103012040)
Device Identifier (DI) Information
DuraFlow
10301204
In Commercial Distribution
ANGIODYNAMICS, INC.
10301204
In Commercial Distribution
ANGIODYNAMICS, INC.
DuraFlow 2 - 15.5F x 36cm Chronic Hemodialysis Catheter Set (with Cuff 31cm from Tip)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
37278 | Double-lumen haemodialysis catheter, implantable |
An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MSD | Catheter, hemodialysis, implanted |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K110936 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Needle Gauge: 18 Gauge |
Catheter Gauge: 15.5 French |
Length: 36 Centimeter |
Device Record Status
b86ee96c-e7a4-4de3-9e14-d22f06e9381d
February 05, 2021
5
September 15, 2015
February 05, 2021
5
September 15, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
H787103012045 | 5 | H787103012040 | In Commercial Distribution | BOX | |
H787103012041 | 1 | H787103012040 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
GS1 | 15051684014762 |
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
[?]
+1(518)795-1676
dgreer@angiodynamics.com
dgreer@angiodynamics.com