OUIEZEN
GUDID 00840388213780
Starkey Laboratories, Inc.
Noninvasive device battery charger| Primary Device ID | 00840388213780 |
| NIH Device Record Key | 8c1f52c7-0f28-44d9-987c-c5d2c8d6f54a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OUIEZEN |
| Version Model Number | OuieZen SL2 Prm Charger RIC R/RT |
| Company DUNS | 055461479 |
| Company Name | Starkey Laboratories, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840388213780 [Primary] |
FDA Product Code
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-23 |
| Device Publish Date | 2026-02-13 |
On-Brand Devices [OUIEZEN]
| 00840388202982 | OUIEZEN 24 SK SG NW CIC |
| 00840388202944 | OUIEZEN 24 SK SG CIC R |
| 00840388210062 | OuieZen 24 OM mRIC R |
| 00840388209806 | OuieZen 12 GS RIC R |
| 00840388209578 | OuieZen 12 GS RIC 312 |
| 00840388210505 | OuieZen 16 OM mRIC R |
| 00840388210246 | OuieZen 16 OM CIC |
| 00840388210024 | OuieZen 24 OM CIC |
| 00840388213780 | OuieZen SL2 Prm Charger RIC R/RT |
| 00840388213773 | OuieZen SL2 Charger RIC R/RT |
| 00840388212684 | OuieZen 12 GS BTE 13 P |
| 00840388212288 | OuieZen 12 GS BTE 13 UP |
Trademark Results [OUIEZEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OUIEZEN 79336474 not registered Live/Pending |
OPTICAL CENTER 2022-02-21 |
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