FDA UDI
In Commercial Distribution
🇺🇸 United States
ABPCare
DI: 00856298006176
·
Model: ABPCare
·
SCOTTCARE CORPORATION, THE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ABPCare
- Primary DI
- 00856298006176
- Version / Model
- ABPCare
- Catalog Number
- 101367
- Company Name
- SCOTTCARE CORPORATION, THE
- Labeler DUNS
- 808204957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 99d19372-32a8-48d3-90fd-181b455eeef3
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 |
|---|---|---|---|---|
| DSK | Computer, Blood-Pressure | Cardiovascular | 870.1110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52523 | Ambulatory services information system application software | An application software program, routines, and/or algorithms intended to be used as or in an information system 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 ambulatory care services [those services provided to patients on an ambulatory basis (e.g., in an emergency department, physician's office, urgent care centre), rather than by admission to a healthcare facility] and facilities. It is available for installation into existing mainframe or decentralized computers/networks. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856298006176 | GS1 |
Customer Contacts
- Phone
- 216-362-0550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021517 | 000 |