FDA UDI
In Commercial Distribution
🇺🇸 United States
ASSURE WCD System
DI: 00840241600047
·
Model: 80014-001
·
Kestra Medical Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASSURE WCD System
- Primary DI
- 00840241600047
- Version / Model
- 80014-001
- Catalog Number
- 80014-001
- Company Name
- Kestra Medical Technologies, Inc.
- Labeler DUNS
- 060944361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-15
- Public Version
- 2
- Public Version Date
- 2022-01-12
- Public Version Status
- Update
- Public Device Record Key
- 1ec079ac-314d-43ad-a010-9bfca975c2a3
Device Description
The ASSURE Wearable Cardioverter Defibrillator System
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| MVK | Wearable Automated External Defibrillator | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48052 | Wearable defibrillation system defibrillator | A portable, battery-powered defibrillator carried by a patient, typically in a shoulder bag, and connected to the body-worn electrodes within the vest of a wearable defibrillation system. It continuously monitors the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and alerts the patient prior to electrical treatment shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the defibrillator activates the electrodes (release of their gel) and delivers the shock to restore normal rhythm. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840241600047 | GS1 |
Customer Contacts
- Phone
- 1.833.692.7787
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200037 | 000 |
| P200037 | 001 |
| P200037 | 002 |
| P200037 | 003 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius