FDA UDI
In Commercial Distribution
🇺🇸 United States
S&W
DI: 10854661006027
·
Model: FS-TB4
·
Leonhard Lang GmbH
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
30
Basic Information
- Brand Name
- S&W
- Primary DI
- 10854661006027
- Version / Model
- FS-TB4
- Catalog Number
- 754-30
- Company Name
- Leonhard Lang GmbH
- Labeler DUNS
- 302846407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0da3c8da-23b7-44d2-b16f-241c553bf5b8
Device Description
ECG Electrodes
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 35035 | Electrocardiographic electrode, single-use | A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30854661006021 | GS1 | case | 4 | In Commercial Distribution | |
| Package | 20854661006024 | GS1 | box | 34 | In Commercial Distribution | |
| Primary | 10854661006027 | GS1 | ||||
| Unit of Use | 00854661006020 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024264 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius