DEVICE: FlexCath™ Select (00643169688858)

Device Identifier (DI) Information

FlexCath™ Select
990065
Not in Commercial Distribution

MEDTRONIC, INC.
00643169688858
GS1
May 10, 2022
1
006261481 *Terms of Use
SHEATH 990065 FLEXCATH SELECT 10 FR 65CM
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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designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications.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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DYB INTRODUCER, CATHETER
DRA CATHETER, STEERABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K163268 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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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)
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Device Record Status

dff59886-98f7-425e-841f-1825f98301ec
July 31, 2023
5
May 19, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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