DEVICE: Gossen Metrawatt SECULIFE (00863313000330)

Device Identifier (DI) Information

Gossen Metrawatt SECULIFE
VL
In Commercial Distribution
M695V
BC GROUP INTERNATIONAL, INC.
00863313000330
GS1

1
602930208 *Terms of Use
Defibrillator Analyzer Variable Load, for use with Seculife DF Base and Seculife DF+ - private labeled for Gossen Metrawatt
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
36791 External defibrillator tester
An electronic instrument used to test an external defibrillator to ensure compliance with performance specifications. The device connects to the output of the defibrillator, typically via contact plates, and measures the energy delivered by the defibrillator into a standard resistive load; it may also perform transcutaneous pacemaker testing, provide waveform information, and execute other quality control procedures. The device may be used to test the function of an external defibrillator periodically, after repair, or for training purposes.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRL Tester, Defibrillator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153210 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

4e01348a-c5a3-4a39-8488-8aeb795a3105
July 06, 2018
3
September 24, 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
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

[?]
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

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
(314) 638-3800
sales@bcgroupintl.com
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