FDA UDI
In Commercial Distribution
🇺🇸 United States
MYO/Wire® Ultra-Thin Temporary Pacing Wires
DI: 08718627410004
·
Model: AU010102
·
A & E MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MYO/Wire® Ultra-Thin Temporary Pacing Wires
- Primary DI
- 08718627410004
- Version / Model
- AU010102
- Company Name
- A & E MEDICAL CORPORATION
- Labeler DUNS
- 173770868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-05
- Public Version
- 5
- Public Version Date
- 2019-02-04
- Public Version Status
- Update
- Public Device Record Key
- 462d9b18-85fa-477e-a9cd-a4a0317d7653
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LDF | ELECTRODE, PACEMAKER, TEMPORARY | Cardiovascular | 870.3680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45966 | Transthoracic pacing lead | A flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor between the heart and an external temporary pacing/defibrillation device used to treat postoperative cardiac arrhythmias/cardiac arrests. The electrode end is attached to the myocardium. The other end initially is typically attached to a removable needle used to perforate the chest wall from the inside out, after which it is connected to a pulse generator, typically via an adaptor. This device is only used for temporary pacing of the heart and is removed once the patient is stable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08718627410011 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08718627410004 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033858 | 000 |