DEVICE: Vado (00810591020222)

Device Identifier (DI) Information

Vado
SS8FMB74
In Commercial Distribution
SS8FMB74
KALILA MEDICAL
00810591020222
GS1
October 01, 2018
1
015986592 *Terms of Use
Steerable Sheath, Bidirectional
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Haemostasis valve A sterile, noninvasive device with a self-sealing lumen (valve) designed as a conduit through which a small diameter diagnostic/interventional device (e.g., 25 French or less) can be introduced into or withdrawn from the patient's vasculature while maintaining haemostasis to reduce blood loss from the patient. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer, torque device). This is a single-use device.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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
Storage Environment Temperature: less than 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

11b48a0a-61fb-4d1e-b950-b3700b3c29d6
March 29, 2018
2
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
Yes
No
No CLOSE

Customer Contact

[?]
+1(650)681-3470
aepcustomerservice@abbott.com
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