Unipower
GUDID 00817392021632
UNIPOWER CORPORATION
Rechargeable battery pack| Primary Device ID | 00817392021632 |
| NIH Device Record Key | f57d52b9-cd49-46c1-9103-faa2e6c1feaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unipower |
| Version Model Number | B11389 |
| Company DUNS | 609162797 |
| Company Name | UNIPOWER CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817392021632 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K940842
FDA Product Code
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [Unipower]
Trademark Results [Unipower]
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