DEVICE: Standard VAVD Kit (B066H11360)

Device Identifier (DI) Information

Standard VAVD Kit
H-1136
In Commercial Distribution
H-1136
NOVOSCI CORP.
B066H11360
HIBCC

1
938289980 *Terms of Use
A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Cardioplegia solution administration kit A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.
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FDA Product Code

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Product Code Product Code Name
DTP Defoamer, Cardiopulmonary Bypass
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K990514 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b75084fa-1ccc-4e18-b258-6149fefc6c3d
July 06, 2018
3
September 26, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B066H11363 10 B066H11360 In Commercial Distribution Case
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
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Customer Contact

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No Customer Contact currently defined
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