Home GUDID 10709078008563 Earmates
Primary DI 10709078008563
Brand Earmates
Company WESTMED, INC.
Model 0440
Device description Earmates, Charcoal (Pair)
Published 2020-06-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name NVO Spacer, Direct Patient Interface
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NVO Spacer, Direct Patient Interface Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10709078008563 Package GS1 50 In Commercial Distribution 00709078008566 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10709078008563 10709078008563 00709078008566 00709078008566 709078008566 0709078008566
GMDN Terms# Term, Definition table Term Definition Patient tube cushion A small patient-worn padding intended to function as a barrier between a patient tube/catheter (e.g., nasogastric tube, oxygen tube, surgical drain, laryngectomy or tracheostomy tube) and the skin to prevent irritation, maceration, and ulceration. It is typically made of a skin-friendly material (e.g., foam, silicone gel) designed to wrap/fit around the tube/catheter. This is a single-use device.
Regulatory Flags# DUNS number 092673953 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#