DEVICE: CVS Health (00050428269381)

Device Identifier (DI) Information

CVS Health
996552
Not in Commercial Distribution
996552
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
00050428269381
GS1
September 21, 2016
1
062312574 *Terms of Use
The Morning & Motion Sickness Band is an elasticated band that can be comfortably worn around the wrist. There is a plastic button-shaped stud inserted through the band. Morning & Motion Sickness Band are designed to be worn around the wrist where the stud exerts a pressure to the Nei-Kuan acupressure point. The Morning & Motion Sickness Band is a simple device used to control nausea and motion sickness without the use of drugs. The device is non-powered and operates by exerting pressure on acupressure points, as such it is non-invasive.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Acupressure wristband A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. The device is typically an adjustable strap made of medical grade thermoplastic material that includes a mechanical pressure dial (a notched wheel) that can be manually rotated by the user to increase or decrease the applied acupressure. It is intended to alleviate nausea caused by various conditions including pregnancy (morning sickness), motion sickness (travel sickness), post anaesthesia sickness, and chemotherapy sickness. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
MVV Device, Acupressure
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K033268 000
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Sterilization

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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

de46fce0-0d9f-41bb-b55d-416ed81b08dc
July 06, 2018
3
September 21, 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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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