Defibrillation Electrodes
Electrode-Multifunction, Pediatric,radiotransparent Element, Compatible W/ Phillips White Barrel Connector
2manufacturers in China registered for this device type
31catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | TZ Medical, Inc., United States |
|---|---|
| FDA product code | DRO |
| Device type | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5550 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-12-30 |
| Record revised | 2023-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P-211-K1 | 10 | In distribution | |
| P-311-Z1 | 10 | In distribution | |
| P-111-K1 | 10 | In distribution | |
| P-122-T1 | 10 | In distribution | |
| P-121-Z1 | 10 | In distribution | |
| P-211-P2 | 10 | In distribution | |
| P-212-Z1 | 10 | In distribution | |
| P-111-M1 | 10 | In distribution | |
| P-212-P1 | 10 | In distribution | |
| P-224-Z1 | 10 | In distribution | |
| P-214-M1 | 10 | In distribution | |
| P-121-T1 | 10 | In distribution | |
| P-111-P2 | 10 | In distribution | |
| P-311-T1 | 10 | In distribution | |
| P-111-T1K | 10 | In distribution | |
| P-112-T1 | 10 | In distribution | |
| P-211-P1 | 10 | In distribution | |
| P-311-M1 | 10 | In distribution | |
| P-111-Z1 | 10 | In distribution | |
| P-211-T1K | 10 | In distribution | |
| P-212-M1 | 10 | In distribution | |
| P-224-T1 | 10 | In distribution | |
| P-214-T1 | 10 | In distribution | |
| P-111-P1 | 10 | In distribution | |
| P-211-T1 | 10 | In distribution | |
| P-122-Z1 | 10 | In distribution | |
| P-211-Z1 | 10 | In distribution | |
| P-311-P2 | 10 | In distribution | |
| P-211-M1 | 10 | In distribution | |
| P-214-Z1 | 10 | In distribution | |
| P-111-T1 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| M Series Biphasic | Zoll Medical Corporation | 97 |
| Medi-Trace Cadence | Cardinal Health | 17 |
| Kendall | Cardinal Health | 5 |
| R Series | Zoll Medical Corporation | 5 |
| HeartStart | Philips Medical Systems Hsg | 2 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Philips Medical Systems Hsg | 2 |
| PAD 3020-XLT | TZ Medical, Inc. | 1 |
| Pedi-Padz | Zoll Medical Corporation | 1 |
| PAD 1115Z | TZ Medical, Inc. | 1 |
| Pad 101NHK | TZ Medical, Inc. | 1 |
| PAD 1114 | TZ Medical, Inc. | 1 |
| PAD 3020-HP | TZ Medical, Inc. | 1 |
Showing 12 of 36. All products under Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983196 | 1999-09-15 |
| K983232 | 1999-09-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-04-30 | Class II | Process control | TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end | US: 10,410 pieces; Outside US: 100 pieces | 2013-09-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA.
Records are records: nothing here is an offer of sale.