Temporary Myocardial Heartwire
- Primary DI
- 00836559001904
- Brand
- Temporary Myocardial Heartwire
- Company
- Oscor Inc.
- Model
- TME 66 TS
- Catalog number
- TME 66 TS
- Device description
- Temporary Myocardial Heartwire
- Published
- 2025-09-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| LDF | ELECTRODE, PACEMAKER, TEMPORARY |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | Cardiovascular | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30836559001905 | Primary | GS1 | 0 | |
| 00836559001904 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 30836559001905 | 30836559001905 | ||
| 00836559001904 | 00836559001904 | 836559001904 | 0836559001904 |
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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Length | 60 | Centimeter |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 101835833
- Device count
- 25
- 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
- true
- 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 |
|---|---|---|---|---|
| 00813502010237 | Introducer Kit for Impella® | 0052-3014 | 0052-3014 | 2017-11-18 |
| 00813502010244 | Introducer Kit for Impella® | 0052-3015 | 0052-3015 | 2017-11-18 |
| 00813502010558 | Introducer Kit for Impella® | 0052-3021 | 0052-3021 | 2017-11-18 |
| 00813502010664 | Introducer Kit for Impella® | 0052-3025 | 0052-3025 | 2017-11-30 |
| 00813502011517 | Introducer Kit for Impella® | 0052-3001 | 0052-3001 | 2017-11-30 |
| 00813502011562 | Introducer Kit for Impella® | 0052-3000 | 0052-3000 | 2017-11-30 |
| 00813502011609 | Introducer Kit for Impella® | 0052-3006 | 0052-3006 | 2017-11-19 |
| 00885672013226 | VV-Plug | 667145-303 | VV-PLUG | 2026-06-01 |
| 00885672013233 | LV-1 Plug | 667147-303 | LV-1 PLUG | 2026-06-01 |
| 00885672013240 | IS4/DF4 Plug | 667148-303 | IS4/DF4 PLUG | 2026-06-01 |
| 00885672012892 | Volante™ | VLT-6.5-45-9-S | VLT-6.5-45-9-S | 2026-05-08 |
| 00885672012908 | Volante™ | VLT-6.5-45-17-S | VLT-6.5-45-17-S | 2026-05-08 |
| 00885672012915 | Volante™ | VLT-6.5-55-7-S-SD | VLT-6.5-55-7-S-SD | 2026-05-08 |
| 00885672012922 | Volante™ | VLT-6.5-55-9-S | VLT-6.5-55-9-S | 2026-05-08 |
| 00885672012939 | Volante™ | VLT-6.5-55-9-S-PF | VLT-6.5-55-9-S-PF | 2026-05-08 |
| 00885672012946 | Volante™ | VLT-6.5-55-17-S | VLT-6.5-55-17-S | 2026-05-08 |
| 00885672012953 | Volante™ | VLT-6.5-90-9-S | VLT-6.5-90-9-S | 2026-05-08 |
| 00885672012960 | Volante™ | VLT-7-45-9-S | VLT-7-45-9-S | 2026-05-08 |
| 00885672012977 | Volante™ | VLT-7-45-17-S | VLT-7-45-17-S | 2026-05-08 |
| 00885672012984 | Volante™ | VLT-7-55-9-S | VLT-7-55-9-S | 2026-05-08 |
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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