DEVICE: Flo-Thru Intraluminal Shunt® (00085412532431)
Device Identifier (DI) Information
Flo-Thru Intraluminal Shunt®
FT-12100
In Commercial Distribution
FT12100
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12100
In Commercial Distribution
FT12100
SYNOVIS LIFE TECHNOLOGIES, INC.
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
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? |
---|---|---|---|---|
47111 | Surgical intravascular shunt |
A sterile device designed to temporarily channel (shunt) intravascular blood through a vascular anastomosis, primarily to control bleeding and enable distal perfusion during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a hollow shaft with atraumatic dilations/bulbs on either end. The shaft is inserted into the lumen of the blood vessel via a small incision at the surgical site allowing blood to flow distal to the site of anastomosis. It is typically made of silicone elastomer and polyester radiopaque materials and is removed upon completion of the intervention. It is available in a range of diameters. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXC | CLAMP, VASCULAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K981624 | 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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No Device Sizes |
Device Record Status
341cc257-bc7b-474b-9c70-f4b2aee2e52a
July 06, 2018
3
September 24, 2016
July 06, 2018
3
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 |
---|---|---|---|---|---|
50085412532436 | 5 | 00085412532431 | In Commercial Distribution | CASE |
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
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com