FDA UDI
In Commercial Distribution
🇺🇸 United States
EKG Patch™ (Large)
DI: 00850018485012
·
Model: Large
·
NULINE SENSORS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EKG Patch™ (Large)
- Primary DI
- 00850018485012
- Version / Model
- Large
- Catalog Number
- MGLRG
- Company Name
- NULINE SENSORS, LLC
- Labeler DUNS
- 079231054
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-01
- Public Version
- 1
- Public Version Date
- 2020-07-09
- Public Version Status
- New
- Public Device Record Key
- 06fce679-7028-4ed7-85fe-8accb9422ba8
Device Description
Electrode, Electrocardiograph
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 62597 | Ambulatory recorder conductive patch | An adhesive patch intended to fix a patient-worn recorder (e.g., electrocardiographic long-term ambulatory recorder) to skin electrodes during long-term electrophysiological recording/monitoring [e.g., electrocardiogram (ECG)], and to transmit the electrical signals from the electrodes to the recorder. It is an electrical conducting patch made of metal and synthetic polymer materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850018485019 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 00850018485012 | GS1 |
Customer Contacts
- Phone
- 407-473-0765
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 27 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Light