FDA UDI
In Commercial Distribution
🇺🇸 United States
Vyaire
DI: 08809083941338
·
Model: 2009101-003P
·
BIOPROTECH INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Vyaire
- Primary DI
- 08809083941338
- Version / Model
- 2009101-003P
- Company Name
- BIOPROTECH INC.
- Labeler DUNS
- 688460539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-15
- Public Version
- 1
- Public Version Date
- 2018-12-17
- Public Version Status
- New
- Public Device Record Key
- 97754aa7-b377-435f-b6c0-c1a1ec959758
Device Description
Adult Resting ECG Electrodes, Aggressive Adhesive
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DRX | Electrode, Electrocardiograph | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35035 | Electrocardiographic electrode, single-use | A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28809083941332 | GS1 | Carton Box | 10 | In Commercial Distribution | |
| Package | 18809083941335 | GS1 | Inner Box | 10 | In Commercial Distribution | |
| Primary | 08809083941338 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040784 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius