FDA UDI In Commercial Distribution 🇺🇸 United States

DRI Sleeper eclipse plus

DI: 00619013000183 · Model: AZ-014 · ANZACARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DRI Sleeper eclipse plus
Primary DI
00619013000183
Version / Model
AZ-014
Company Name
ANZACARE LIMITED
Labeler DUNS
590486213
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-02-16
Public Version
1
Public Version Date
2026-02-24
Public Version Status
New
Public Device Record Key
15ef16d8-95fb-42bb-8e38-47d6ed9aeb3c

Device Description

Wireless bedwetting alarm for children including a parental alarm

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KPN Alarm, Conditioned Response Enuresis

GMDN Terms

Code Name
11588 Incontinence sensor/alarm

Identifiers

Type ID
Primary 00619013000183

Customer Contacts

Phone
18773312768