DEVICE: DuraFlow (H787103003010)
Device Identifier (DI) Information
DuraFlow
10300301
In Commercial Distribution
ANGIODYNAMICS, INC.
10300301
In Commercial Distribution
ANGIODYNAMICS, INC.
7F Double Access Hemodialysis Set
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LFK | CATHETER, FEMORAL |
LFJ | CATHETER, SUBCLAVIAN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 7 French |
Device Record Status
c2d706a1-dc8e-419f-a472-5c46f75f342d
February 05, 2021
3
September 15, 2015
February 05, 2021
3
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 |
---|---|---|---|---|---|
H787103003015 | 5 | H787103003010 | In Commercial Distribution | BOX |
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
[?]
+1(518)795-1676
dgreer@angiodynamics.com
dgreer@angiodynamics.com