FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Covidien
DI: 10817357020110
·
Model: 33103
·
HYGIA HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Covidien
- Primary DI
- 10817357020110
- Version / Model
- 33103
- Company Name
- HYGIA HEALTH SERVICES, INC.
- Labeler DUNS
- 177939027
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 3
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- 999500db-f450-4354-a112-416bb32bbba6
- Distribution End Date
- 2019-05-10
Device Description
Covidien Disposable 3 Lead System
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
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61812 | Electrocardiographic lead set, reprocessed | A collection of non-sterile, noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30817357020114 | GS1 | Box | 10 | Not in Commercial Distribution | 2021-03-19 |
| Primary | 10817357020110 | GS1 | ||||
| Package | 50817357020118 | GS1 | Case | 10 | Not in Commercial Distribution | 2021-03-19 |