FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HearTwave II
DI: 10841522123085
·
Model: 90200
·
SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HearTwave II
- Primary DI
- 10841522123085
- Version / Model
- 90200
- Catalog Number
- 707-0003-00
- Company Name
- SPACELABS HEALTHCARE (WASHINGTON), INC
- Labeler DUNS
- 145581588
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-11
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 06fb4f7a-c693-492e-91d0-0ec1284e235c
- Distribution End Date
- 2018-05-15
Device Description
PM-3 PATIENT MODULE KIT,90200
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
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36145 | Cardiac stress exercise monitoring system | An assembly of devices comprising a stress exercise monitoring system designed to record electrocardiograph (ECG) signals from electrodes placed on a patient's limbs and chest while the patient engages in varying degrees of exercise on a device or system of a predetermined kind, e.g., an ergometer. The system will typically analyse the recorded data, display results, monitor various functions, provide control of the workload, and give printouts, providing the clinician with a complete representation of the electrical activity of the heart, including heart rate. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841522123085 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050225 | 000 |