| Primary Device ID | 00619013000015 |
| NIH Device Record Key | 7afc544b-98f9-4b61-b78a-253529ddb18c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRI Sleeper excel |
| Version Model Number | AZ-001 |
| Company DUNS | 590486213 |
| Company Name | ANZACARE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 18773312768 |
| info@dri-sleeper.com | |
| Phone | 18773312768 |
| info@dri-sleeper.com | |
| Phone | 18773312768 |
| info@dri-sleeper.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00619013000015 [Primary] |
| KPN | Alarm, Conditioned Response Enuresis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-24 |
| Device Publish Date | 2026-02-16 |
| 00619013000015 - DRI Sleeper excel | 2026-02-24Enuresis alarm for children with plug-in sensor |
| 00619013000015 - DRI Sleeper excel | 2026-02-24 Enuresis alarm for children with plug-in sensor |
| 00619013000039 - DRI Sleeper eclipse | 2026-02-24 wireless enuresis alarm |
| 00619013000183 - DRI Sleeper eclipse plus | 2026-02-24 Wireless bedwetting alarm for children including a parental alarm |
| 00619013000091 - DRI Eclipse | 2019-01-08 DRI Eclipse wireless bedwetting alarm by Anzacare |
| 00619013000107 - DRI Excel | 2019-01-08 DRI Excel bedwetting alarm by Anzacare |