FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelliSpace Perinatal
DI: 00884838084483
·
Model: IntelliSpace Perinatal K Large Arch.
·
Philips Medical Systems Hsg
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IntelliSpace Perinatal
- Primary DI
- 00884838084483
- Version / Model
- IntelliSpace Perinatal K Large Arch.
- Catalog Number
- 867061
- Company Name
- Philips Medical Systems Hsg
- Labeler DUNS
- 790605856
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-07
- Public Version
- 5
- Public Version Date
- 2022-02-16
- Public Version Status
- Update
- Public Device Record Key
- 36a04fd9-e9fa-488a-a286-9b2c2bf6fb51
Device Description
IntelliSpace Perinatal Large Architecture is a software-only offering and includes three separate versions of IntelliSpace Perinatal.
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 |
| DSJ | Alarm, Blood-Pressure | Cardiovascular | 870.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36230 | Obstetrics 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 administrative and clinical activities associated with the provision and utilization of obstetrical services and facilities. 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 | 00884838084483 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]