FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED
DI: 00842180176096
·
Model: 5997-2
·
ELMED INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELMED
- Primary DI
- 00842180176096
- Version / Model
- 5997-2
- Catalog Number
- 5997-2
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-21
- Public Version
- 1
- Public Version Date
- 2023-08-29
- Public Version Status
- New
- Public Device Record Key
- 9c50976d-1461-4019-8e26-7d004b950ab8
Device Description
MICRO COAG ADAPTOR WITH .206 PHONO PLUG AND FEMALE BANANA FOR ANALIZING TEST
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37946 | Leakage current tester | A battery-powered instrument intended to be used to perform either alternating current (AC) or direct current (DC) leakage testing on electronic equipment. It typically includes an Amperimeter that can measure in a range of milliamperes/amperes and appropriate accessories (e.g., leads, clips) to perform the measurements. The device may determine leakage current in medical device chassis and patient leads, preventing patient risks (e.g., heart fibrillation). Some devices include visual and/or sound alarms that operate when a pre-set value is reached. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842180176096 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181173 | 000 |