FDA UDI
In Commercial Distribution
🇺🇸 United States
Mactrode
DI: 70885403258901
·
Model: 2066867-014
·
Carefusion Finland 320 Oy
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
14
Basic Information
- Brand Name
- Mactrode
- Primary DI
- 70885403258901
- Version / Model
- 2066867-014
- Catalog Number
- 2066867-014
- Company Name
- Carefusion Finland 320 Oy
- Labeler DUNS
- 367919120
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 14
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 70d9b997-54cf-40b1-bb28-cdd0cf7e73a2
Device Description
Mactrode™ Wide Mouth Clips for 15-lead
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
- Yes
- 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 |
|---|---|---|---|---|
| DRX | Electrode, electrocardiograph | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60635 | Electrocardiographic electrode connector | A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patient’s skin, with a socket at the other end for a plug on the lead. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20885403258906 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 70885403258901 | GS1 | ||||
| Unit of Use | 10885403258909 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]