| Primary Device ID | 10810725023089 |
| NIH Device Record Key | d9340328-dfe4-4219-8da0-7309ea9ef3a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ameda, Inc |
| Version Model Number | 10004 |
| Catalog Number | 10004 |
| Company DUNS | 078719435 |
| Company Name | AMEDA, INC. |
| Device Count | 2 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | true |
| Phone | (866) 992-6332 |
| parentcare@ameda.com | |
| Phone | (866) 992-6332 |
| parentcare@ameda.com |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810725023082 [Primary] |
| GS1 | 00810725023198 [Unit of Use] |
| GS1 | 10810725023089 [Package] Contains: 00810725023082 Package: Outer Carton [50 Units] In Commercial Distribution |
| HGX | Pump, Breast, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00810725026168 - Ameda, Inc. | 2025-09-17 Pearl Trolley Attachment Screws and Washers (1Set) |
| 00810725026175 - Ameda, Inc. | 2025-09-17 Pearl Trolley Non-Locking Casters Wheel |
| 00810725026182 - Ameda, Inc. | 2025-09-17 Pearl Trolley Locking Casters Wheel |
| 00810725026199 - Ameda, Inc. | 2025-09-17 Pearl Case Shoulder Strap |
| 00810725026205 - Ameda, Inc. | 2025-09-17 Pearl Case Latches |
| 00810725026212 - Ameda, Inc. | 2025-09-17 Pearl Electric Breast Pump with Hard Case |
| 00810725026250 - Ameda, Inc. | 2025-09-17 Ameda Pearl Electric Breast Pump with Hard Case and Cooler |
| 10810725025823 - Ameda | 2022-10-18 Dual milk collection system |