FDA UDI
In Commercial Distribution
🇺🇸 United States
ASSURE Wearable ECG
DI: 00840241600313
·
Model: 80553-001
·
Kestra Medical Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASSURE Wearable ECG
- Primary DI
- 00840241600313
- Version / Model
- 80553-001
- Catalog Number
- 80553-001
- Company Name
- Kestra Medical Technologies, Inc.
- Labeler DUNS
- 060944361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-18
- Public Version
- 1
- Public Version Date
- 2024-09-26
- Public Version Status
- New
- Public Device Record Key
- 0dbf56d5-3427-433c-affe-196715ace4da
Device Description
A wearable cardiac episode recorder
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
- 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 |
|---|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62641 | Electrocardiograph, home-use | A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840241600313 | GS1 |
Customer Contacts
- Phone
- 1.833.692.7787
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233864 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius