FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ZIO SR Patch
DI: 00869770000234
·
Model: K100A101X
·
IRHYTHM TECHNOLOGIES, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZIO SR Patch
- Primary DI
- 00869770000234
- Version / Model
- K100A101X
- Company Name
- IRHYTHM TECHNOLOGIES, INC.
- Labeler DUNS
- 861237670
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- d24a589c-828f-4dc6-8360-4fbe2cff7866
- Distribution End Date
- 2017-05-31
Device Description
ZIO SR ECG Monitoring Service
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | Cardiovascular | 870.2920 | 2 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35162 | Electrocardiographic ambulatory recorder | An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869770000234 | GS1 |