FDA UDI
In Commercial Distribution
🇺🇸 United States
Fetal Monitor Remote Display
DI: B321600225000
·
Model: 27 DeskTop
·
CLINICOMP INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fetal Monitor Remote Display
- Primary DI
- B321600225000
- Version / Model
- 27 DeskTop
- Company Name
- CLINICOMP INTERNATIONAL, INC.
- Labeler DUNS
- 113412019
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2020-05-19
- Public Version Status
- Update
- Public Device Record Key
- 398bf38c-c615-4531-87a0-052d8c6438af
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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38470 | Centralized patient monitor | A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B321600225000 | HIBCC |
Customer Contacts
- Phone
- 8003508202
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K931133 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 36 | Pound | |
| Height | 19 | Inch | |
| Width | 26 | Inch | |
| Length | 10 | Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 35 Degrees Celsius