FDA UDI
In Commercial Distribution
🇺🇸 United States
ADVANCED PATIENT MONITOR
DI: B510PM200M1
·
Model: PM-200M
·
ADVANCED INSTRUMENTATIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ADVANCED PATIENT MONITOR
- Primary DI
- B510PM200M1
- Version / Model
- PM-200M
- Company Name
- ADVANCED INSTRUMENTATIONS, INC.
- Labeler DUNS
- 608736880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-11
- Public Version
- 1
- Public Version Date
- 2020-04-20
- Public Version Status
- New
- Public Device Record Key
- d06e7590-b34d-4248-ae80-019578c3016f
- Distribution End Date
- 2028-01-05
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
- 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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37595 | Multiple-patient intensive/general healthcare physiologic monitoring system | An assembly of electrically-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of more than one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and bedside patient monitors to provide data from each patient; it often includes programmable alarms, portable radio transmitters (with sensors), receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B510PM200M1 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131898 | 000 |