DEVICE: ReadyRip Belt (B143502020440)

Device Identifier (DI) Information

ReadyRip Belt
Extra Large - Single
In Commercial Distribution
502-0204-4
Cleveland Medical Devices Inc.
B143502020440
HIBCC

1
557510625 *Terms of Use
Single use, extra large respiratory belt.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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
Electroencephalograph A line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.
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FDA Product Code

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Product Code Product Code Name
GWQ Full-Montage Standard Electroencephalograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042039 000
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Sterilization

No
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

b4dc492f-74d7-473d-a324-e2ba676f5c1d
July 06, 2018
3
September 16, 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
B14360201041 25 B143502020440 In Commercial Distribution
B14360201011 10 B143502020440 In Commercial Distribution
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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
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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