DEVICE: INVIVE™ (00802526536625)

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Device Record History
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Device Identifier (DI) Information
INVIVE™
V172
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
00802526536625
GS1

1
106295384 *Terms of Use
Cardiac Resynchronization Therapy Pacemaker
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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?
31704 Cardiac pulse generator test magnet
A magnetized device used to test an inhibited or triggered type of pacemaker or defibrillator, and cause an inhibited or triggered generator to revert to asynchronous operation. The device is placed on the outside of the patient's thorax over the pacemaker/defibrillator for analysis of the implanted device's function. The magnet will activate the magnet sensitive relay in the pacemaker/defibrillator and will change the function of the implanted device. It is possible to evaluate the function of the implanted device via an electrocardiograph.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P030005 099
P030005 106
P030005 107
P030005 113
P030005 116
P030005 138
P030005 176
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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
03bd79ea-812f-4352-a899-df6151f95c24
December 11, 2018
4
September 24, 2014
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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
No Package DIs found
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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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No
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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