DEVICE: Pharmaceutical Innovations (00300363000557)

Device Identifier (DI) Information

Pharmaceutical Innovations
LECTRON II Electrode Conductivity Gel
In Commercial Distribution
36-3000-55
PHARMACEUTICAL INNOVATIONS INC
00300363000557
GS1

1
067486548 *Terms of Use
LECTRON II Electrode Conductivity Gel: 55 Gallon Drum
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Electrode gel A medium for transmission of electrical signals between an electrode and the body and for reduction of isolation ability of the skin. It is usually used in conjunction with electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
GYB Media, Electroconductive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

c884dc5e-0f87-4d81-bdec-80b0cd81f958
March 29, 2018
2
September 14, 2016
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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
10300363000554 1 00300363000557 In Commercial Distribution
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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

[?]
973-242-2900
info@pharminnovations.com
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