FDA UDI
In Commercial Distribution
🇺🇸 United States
LifeVest Wearable Defibrillator
DI: 00855778005050
·
Model: LifeVest 3000 Modem
·
ZOLL MANUFACTURING CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LifeVest Wearable Defibrillator
- Primary DI
- 00855778005050
- Version / Model
- LifeVest 3000 Modem
- Catalog Number
- 10A0924
- Company Name
- ZOLL MANUFACTURING CORPORATION
- Labeler DUNS
- 079320559
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-02-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 05d2dcfd-07cb-400f-995b-670ecb1a2208
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 48051 | Wearable defibrillation system | An assembly of devices worn by a patient to continuously monitor the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and to defibrillate the heart (restore normal rhythm) with electrical shocks. Monitoring is performed with dry, non-adhesive electrodes and the patient is alerted by the device prior to electrical shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the system releases gel over the electrodes and delivers a shock. The system consists of a wearable vest containing the electrodes and a portable defibrillator carried by the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855778005050 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010030 | 001 |