AccessGUDID - DEVICE: Caps Warmer (E22190011)

GUDID

Device Identifier (DI) Information

Brand Name: Caps Warmer
Version or Model: 9001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VOCO GmbH

Primary DI Number: E22190011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

Device Description: Device for temporary heating of dental composites in order to improve application properties.

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):	Yes
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?
31810	Anaesthesia warmer	A mains electricity (AC-powered) heating device into which tubes containing anaesthetic solutions are placed intended to warm the solution prior to it being administered to a patient for anaesthesia. It typically consists of a tabletop device that has wells for the anaesthetic solution tubes, a heating element, a thermostat and operating controls. It is designed to be portable for use in different locations where anaesthesia is administered.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFC	Warmer, Anesthetic Tube
EEG	Heat Source For Bleaching Teeth
EBZ	Activator, Ultraviolet, For Polymerization

FDA Premarket Submission

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

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: f70bd4db-3422-4020-87c1-18e8ca28092f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 21, 2017