FDA UDI
In Commercial Distribution
🇺🇸 United States
ESA 615
DI: 00850540007034
·
Model: ESA615-10-NA220
·
FLUKE ELECTRONICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ESA 615
- Primary DI
- 00850540007034
- Version / Model
- ESA615-10-NA220
- Catalog Number
- 4132164
- Company Name
- FLUKE ELECTRONICS CORPORATION
- Labeler DUNS
- 002687614
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 1
- Public Version Date
- 2018-06-25
- Public Version Status
- New
- Public Device Record Key
- d22feff6-98bf-43a6-baff-30a0f3b60f56
Device Description
Electrical Safety Analyzer
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
- 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
- No
- 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 |
|---|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36796 | Electrical safety tester | An instrument designed to manually and/or automatically verify the safety of electrically-powered medical devices. It typically includes an electric current meter that can measure the alternating current (AC) and direct current (DC) in micro- and mili-amperes with a frequency response that complies with appropriate standards. The device can perform AC and DC leakage-current measurements (typically in the range of 1 A to 20 mA) and resistance-to-ground assessments using two- and/or four-terminal techniques in devices up to several ohms; it may also perform patient lead isolation tests in multiple-electrode devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850540007034 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius