Home GUDID 00619013000015 DRI Sleeper excel
Primary DI 00619013000015
Brand DRI Sleeper excel
Company ANZACARE LIMITED
Model AZ-001
Device description Enuresis alarm for children with plug-in sensor
Published 2026-02-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KPN Alarm, Conditioned Response Enuresis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KPN Alarm, Conditioned Response Enuresis Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00619013000015 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 00619013000015 00619013000015 619013000015 0619013000015
GMDN Terms# Term, Definition table Term Definition Incontinence sensor/alarm A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility.
Regulatory Flags# DUNS number 590486213 Device count 1 Premarket exempt true Lot or batch true Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10193489082739 FITRIGHT MEDLINE INDUSTRIES, INC. KPN 2026-03-05 00193489036414 FITRIGHT MEDLINE INDUSTRIES, INC. KPN 2026-03-05 10193489036411 FITRIGHT MEDLINE INDUSTRIES, INC. KPN 2026-03-05 20193489082736 FITRIGHT MEDLINE INDUSTRIES, INC. KPN 2026-03-05 00619013000039 DRI Sleeper eclipse ANZACARE LIMITED KPN 2026-02-16 00619013000183 DRI Sleeper eclipse plus ANZACARE LIMITED KPN 2026-02-16 00854950002689 Chummie Theos Medical Systems, Inc. KPN 2026-01-01 00854950002696 Chummie Theos Medical Systems, Inc. KPN 2026-01-01 00854950002702 Chummie Theos Medical Systems, Inc. KPN 2026-01-01 00854950002719 Chummie Theos Medical Systems, Inc. KPN 2026-01-01 00856455007428 Wicked Smart Wicked Sheets, LLC KPN 2025-11-19 00854950002023 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002030 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002047 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002078 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002085 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002153 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002177 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002184 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002191 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002207 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002269 Guardian Theos Medical Systems, Inc. KPN 2024-01-04 00854950002283 Shield Theos Medical Systems, Inc. KPN 2024-01-04 00854950002290 Shield Theos Medical Systems, Inc. KPN 2024-01-04 00854950002320 Chummie Theos Medical Systems, Inc. KPN 2024-01-04 00854950002559 NewU Theos Medical Systems, Inc. KPN 2024-01-04 00854950002566 Smart Theos Medical Systems, Inc. KPN 2024-01-04 00854950002573 Zest Theos Medical Systems, Inc. KPN 2024-01-04 00854950002580 Smart Theos Medical Systems, Inc. KPN 2024-01-04 00854950002597 Shield Theos Medical Systems, Inc. KPN 2024-01-04
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