FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMC
DI: 00849593018043
·
Model: 590318
·
Advantage Medical Electronics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AMC
- Primary DI
- 00849593018043
- Version / Model
- 590318
- Catalog Number
- KT-RTR5723
- Company Name
- Advantage Medical Electronics, LLC
- Labeler DUNS
- 080242300
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-10
- Public Version
- 4
- Public Version Date
- 2025-03-20
- Public Version Status
- Update
- Public Device Record Key
- 70feece2-52da-4152-976b-ef1bbcb6acf6
- Distribution End Date
- 2025-03-19
Device Description
ECG LEAD WIRES, 3-LEAD SET, RT CARBON, AHA, 24 IN
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35562 | Electrocardiographic lead set, reusable | A collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849593018043 | GS1 |
Customer Contacts
- Phone
- 954-345-9800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992524 | 000 |