Invenia H5014PM
GUDID 00840682100014
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system| Primary Device ID | 00840682100014 |
| NIH Device Record Key | e7749c6d-be38-4d6e-bd82-e71c00c50991 |
| Commercial Distribution Discontinuation | 2015-09-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Invenia |
| Version Model Number | ABUS System |
| Catalog Number | H5014PM |
| Company DUNS | 078863378 |
| Company Name | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC |
| 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 | 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 Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Altitude: 0 to 5,000m |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682100014 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P110006
FDA Product Code
| PAA | Automated Breast Ultrasound |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [Invenia]
| 00840682100090 | ABUS Review Software |
| 00840682141161 | ABUS 2.0 |
| 00840682141109 | ABUS Viewer |
| 00840682100038 | ABUS Workstation |
| 00840682100021 | ABUS Scan Station |
| 00840682100014 | ABUS System |
Trademark Results [Invenia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVENIA 85933561 4589769 Live/Registered |
General Electric Company 2013-05-16 |
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