FDA UDI
In Commercial Distribution
🇺🇸 United States
CENTRICITY
DI: 00840682102681
·
Model: PERINATAL6.96
·
GE HEALTHCARE
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CENTRICITY
- Primary DI
- 00840682102681
- Version / Model
- PERINATAL6.96
- Company Name
- GE HEALTHCARE
- Labeler DUNS
- 054324257
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-01
- Public Version
- 5
- Public Version Date
- 2020-02-04
- Public Version Status
- Update
- Public Device Record Key
- f1e18792-3971-4b41-a5f1-1c28e0f73cd5
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HGM | SYSTEM, MONITORING, PERINATAL | Obstetrics/Gynecology | 884.2740 | 2 |
| MSX | SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38473 | Patient health record information system | A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. The system typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682102681 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111614 | 000 |