FDA UDI
In Commercial Distribution
🇺🇸 United States
Invenia
DI: 00195278756138
·
Model: ABUS R2.5 Prime
·
GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Invenia
- Primary DI
- 00195278756138
- Version / Model
- ABUS R2.5 Prime
- Catalog Number
- H5023S2-H5013S2
- Company Name
- GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
- Labeler DUNS
- 119309548
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 2
- Public Version Date
- 2026-02-18
- Public Version Status
- Update
- Public Device Record Key
- 55962260-fd61-4d44-a8ca-53659946821f
Device Description
Invenia ABUS Prime
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PAA | Automated Breast Ultrasound | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40761 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195278756138 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P110006 | 011 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storing condition Altitude: 0 to 5000 meters
- Type
- Special Storage Condition, Specify
- Special Conditions
- Operating condition Altitude: 0 to 3000 meters