AccessGUDID - DEVICE: Sea-Band (00008727000013)

GUDID

Device Identifier (DI) Information

Brand Name: Sea-Band
Version or Model: Adult
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEA-BAND LIMITED

Primary DI Number: 00008727000013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 238545748 *Terms of Use

Device Description: The Sea-Band is an elasticated band that can be comfortably worn around the wrist. There is a plastic button-shaped stud inserted through the band. Sea-Bands are designed to be worn around the wrist where the stud exerts a pressure to the Nei-Kuan acupressure point. The Sea-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, and non-sterile.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58072	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVV	Device, Acupressure

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: be67741e-a07f-4b76-bd7f-1b3aa509eee6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016