FDA UDI
In Commercial Distribution
🇺🇸 United States
CENTRICITY PERINATAL
DI: 00195278454386
·
Model: 6.99
·
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CENTRICITY PERINATAL
- Primary DI
- 00195278454386
- Version / Model
- 6.99
- Company Name
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- Labeler DUNS
- 006580799
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-30
- Public Version
- 1
- Public Version Date
- 2022-06-07
- Public Version Status
- New
- Public Device Record Key
- a7dc26ac-e91d-4c92-a48c-e749c5b2a534
Device Description
MD CPN 6.99 MEDICAL DEVICE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
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 | 00195278454386 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111614 | 000 |