Home GUDID 00845819082003 Oasis REST & RELIEF Single-Use
Primary DI 00845819082003
Brand Oasis REST & RELIEF Single-Use
Company OASIS MEDICAL, INC.
Model OM8200
Device description Oasis REST & RELIEF Single-Use Packaging Configuration: Case as Each, Qty: 10 Masks
Published 2026-08-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name IMD Pack, Hot Or Cold, Disposable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IMD Pack, Hot Or Cold, Disposable Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00845819082003 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 00845819082003 00845819082003 845819082003 0845819082003
GMDN Terms# Term, Definition table Term Definition Eye hot/cold therapy mask, single-use A non-powered device intended to be placed over closed eyes to apply heat/steam and/or cold to the eyes for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is typically in the form of a mask-shaped fabric envelope which either: 1) contains a thermal-insulating substance intended to be heated in a microwave oven or cooled in a freezer prior to use; or 2) includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated. Some types have a non-pharmaceutical antimicrobial coating to reduce eye infection risk. This is a single-use device.
Regulatory Flags# DUNS number 194121018 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 true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00845819083000 Oasis REST & RELIEF Plus Single-Use OM8300 2026-08-14 00845819006344 Surgeon's Choice Card SCK 2004, B-SCK 2004 2023-06-30 00845819006375 Surgeon's Choice Card SCK 2005, B-SCK 2005 2023-06-30 10845819005481 SOFT PLUG® Extended Duration Plugs 504 2023-07-31 10845819005474 SOFT PLUG® Extended Duration Plugs 503 2023-06-30 10845819005498 SOFT PLUG® Extended Duration Plugs 505 2023-06-30 00845819000076 Oasis REST & RELIEF Eye Mask OM8000 2023-06-30 00845819003138 Surgeon's Choice Card SCK-2012, B-SCK-2012 2025-10-02 00845819020111 Surgeon's Choice Card SCK 2011 2024-11-07 10845819020118 Surgeon's Choice Card B-SCK 2011 2024-11-07 00845819002919 Premier Edge® Microsurgical Knives PE3128-SL, B-PE3128-SL 2023-12-31 00845819002926 Premier Edge® Microsurgical Knives PE3818, B-PE3818 2023-12-31 10845819002916 Premier Edge® Microsurgical Knives PE3128-SL, B-PE3128-SL 2023-12-31 10845819002923 Premier Edge® Microsurgical Knives PE3818, B-PE3818 2023-12-31 00845819002988 Surgeon's Choice Card SCK 2009, B-SCK 2009 2023-12-27 00845819002971 Surgeon's Choice Card SCK 2009, B-SCK 2009 2023-12-27 10845819002985 Surgeon's Choice Card SCK 2009, B-SCK 2009 2023-12-27 00845819002322 Premier Edge® Microsurgical Knives PE4827-TL, B-PE4827-TL 2023-04-30 00845819000267 SOFT PLUG® Extended Duration Plugs 6400V 2023-07-31 10845819000219 SOFT PLUG® Extended Duration Plugs 6402, 6402-A 2023-07-31
Other Devices Sharing Product Codes# 
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