ETHICON
- Primary DI
- 30705031050970
- Brand
- ETHICON
- Company
- ETHICON, LLC
- Model
- TPW80
- Catalog number
- TPW80
- Device description
- Temporary Cardiac Pacing Wire
- Published
- 2015-09-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
xxx.xxxProduct Codes#
| Code | Name |
|---|---|
| LDF | ELECTRODE, PACEMAKER, TEMPORARY |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | Cardiovascular | 2 |
Premarket Submissions#
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30705031050970 | Package | GS1 | 12 | In Commercial Distribution |
| 10705031050976 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30705031050970 | 30705031050970 |
| 10705031050976 | 10705031050976 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 | 25 Degrees Celsius | |
| Storage Environment Temperature | 0 | 77 Degrees Fahrenheit |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(877)384-4266 | xxx@xxx.xxx |
Regulatory Flags#
- DUNS number
- 829465157
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10705031001435 | ETHILON | 1629H | 1629H | 2015-09-01 |
| 10705031006393 | ETHILON | 585H | 585H | 2015-09-01 |
| 10705031007703 | ETHILON | 661H | 661H | 2015-09-01 |
| 10705031007789 | ETHILON | 663H | 663H | 2015-09-01 |
| 10705031007918 | ETHILON | 669H | 669H | 2015-09-01 |
| 10705031008724 | PERMA-HAND | 706G | 706G | 2015-09-01 |
| 10705031129931 | ETHICON | W945 | W945 | 2026-05-18 |
| 10705031239777 | ETHIBOND EXCEL | X4B37G | X4B37G | 2018-01-25 |
| 10705031239784 | ETHIBOND EXCEL | X4B77G | X4B77G | 2018-01-31 |
| 10705031462144 | ETHIBOND EXCEL | 10X52N | 10X52N | 2019-07-04 |
| 10705031462168 | ETHIBOND EXCEL | 10X72N | 10X72N | 2019-07-04 |
| 10705031462175 | ETHIBOND EXCEL | 10X66N | 10X66N | 2019-07-04 |
| 10705031468214 | ETHIBOND EXCEL | D7576N | D7576N | 2021-05-08 |
| 10705031468221 | ETHIBOND EXCEL | D10048N | D10048N | 2021-05-08 |
| 10705031468238 | ETHIBOND EXCEL | D7581N | D7581N | 2021-05-08 |
| 10705031468245 | ETHIBOND EXCEL | D7924N | D7924N | 2021-05-08 |
| 10705031468276 | ETHIBOND EXCEL | D8492N | D8492N | 2021-05-08 |
| 10705031468320 | ETHIBOND EXCEL | D9079N | D9079N | 2021-05-08 |
| 10705031468344 | ETHIBOND EXCEL | D9329N | D9329N | 2021-05-08 |
| 10705031468351 | ETHIBOND EXCEL | D9607N | D9607N | 2021-05-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 08886483507166 | Bipolar Pacing Catheter | BIOPTIMAL INTERNATIONAL PTE. LTD. | LDF | 2026-05-04 |
| 10801902216110 | ARROW | TELEFLEX INCORPORATED | LDF | 2023-07-14 |
| 10801902198386 | ARROW | TELEFLEX INCORPORATED | LDF | 2022-11-18 |
| 08718627412701 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2016-04-25 |
| 08718627411674 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
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| 08718627411872 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627411896 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627411919 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627411933 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627411957 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627411971 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627411995 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412015 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412039 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412053 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412077 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412091 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412114 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412138 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412152 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |
| 08718627412176 | MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E MEDICAL CORPORATION | LDF | 2015-11-11 |