DEVICE: FlexCath™ Select (00643169688858)
Device Identifier (DI) Information
FlexCath™ Select
990065
Not in Commercial Distribution
MEDTRONIC, INC.
990065
Not in Commercial Distribution
MEDTRONIC, INC.
SHEATH 990065 FLEXCATH SELECT 10 FR 65CM
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? |
---|---|---|---|---|
36079 | Haemostasis valve |
A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | INTRODUCER, CATHETER |
DRA | CATHETER, STEERABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K163268 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep dry |
Special Storage Condition, Specify: Fragile, handle with care |
Storage Environment Humidity: less than 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Handling Environment Temperature: between -31 and 136 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Usable length 65 cm |
Device Size Text, specify: Dilator inner diameter 1 mm |
Device Size Text, specify: Sheath inner diameter 10 Fr (3.3 mm) |
Device Record Status
dff59886-98f7-425e-841f-1825f98301ec
July 31, 2023
5
May 19, 2017
July 31, 2023
5
May 19, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com