AccessGUDID - DEVICE: Dickson Paraffin Bath (00645724004066)

GUDID

Device Identifier (DI) Information

Brand Name: Dickson Paraffin Bath
Version or Model: PB-105B-CORD1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PB105BCORD1
Company Name: Whitehall Manufacturing Co

Primary DI Number: 00645724004066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008312423 *Terms of Use

Device Description: PB105-PARAFFIN BATH 220V EUROPEAN CORD

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":	No
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?
35232	Physical therapy paraffin wax bath	A mains electricity (AC-powered) tub/enclosure, with an internal heating assembly, intended to be filled with liquid paraffin wax for physical therapy. Symptomatic parts of the body (e.g., hands, fingers) are placed in the heated paraffin to relieve pain and stiffness caused by arthritis or other joint inflammation, muscle spasms, or to help stimulate circulation. Temperature settings and timing controls are typically included as part of the device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMC	Bath, Paraffin

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 64f21534-8e83-4712-b453-22ad3c60c625
Public Version Date: December 13, 2018
Public Version Number: 1
DI Record Publish Date: November 12, 2018