FDA UDI
In Commercial Distribution
🇺🇸 United States
Pathfinder
DI: 10841522125645
·
Model: 98000, 98200
·
SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pathfinder
- Primary DI
- 10841522125645
- Version / Model
- 98000, 98200
- Catalog Number
- 040-1726-01
- Company Name
- SPACELABS HEALTHCARE (WASHINGTON), INC
- Labeler DUNS
- 145581588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-03
- Public Version
- 7
- Public Version Date
- 2020-04-15
- Public Version Status
- Update
- Public Device Record Key
- 99acf554-b467-460e-ac60-25bcbbe67efe
Device Description
PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | Cardiovascular | 870.1425 | 2 |
| DXH | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE | Cardiovascular | 870.2920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36827 | Electrocardiographic long-term ambulatory recording analyser | An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person. | No | Active |
| 44098 | Cardiology 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 cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841522125645 | GS1 |