FDA UDI
In Commercial Distribution
🇺🇸 United States
Impulse 7010
DI: 00850540007140
·
Model: IMPULSE 7010
·
FLUKE ELECTRONICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Impulse 7010
- Primary DI
- 00850540007140
- Version / Model
- IMPULSE 7010
- Catalog Number
- 3158544
- 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
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 4f2850a5-7a3e-4f1c-be85-b3b3d7d9571c
Device Description
Defibrillator Selectable Load Accessory
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 |
|---|---|---|---|---|
| DRL | Tester, Defibrillator | Cardiovascular | 870.5325 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36791 | External defibrillator tester | An electronic instrument used to test an external defibrillator to ensure compliance with performance specifications. The device connects to the output of the defibrillator, typically via contact plates, and measures the energy delivered by the defibrillator into a standard resistive load; it may also perform transcutaneous pacemaker testing, provide waveform information, and execute other quality control procedures. The device may be used to test the function of an external defibrillator periodically, after repair, or for training purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850540007140 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083347 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius