PK-141/2.8m
Catalogue number 353181, listed by Biotronik SE & Co. KG, Germany, under Analyzer, Pacemaker Generator Function. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Biotronik SE & Co. KG, Germany |
|---|---|
| FDA product code | DTC |
| Device type | Analyzer, Pacemaker Generator Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3630 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083674 |
| Record published | 2021-05-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 32 to 122 °F; Storage environment humidity 20 to 75 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 353181 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| External Pacemaker Analyzer | Netech Corp. | 2 |
| CareLink SmartSync™ Common Application | Medtronic, Inc. | 2 |
| CareLink SmartSync™ Azure Astra Application | Medtronic, Inc. | 1 |
| CareLink SmartSync™ | Medtronic, Inc. | 1 |
| External Pacemaker Ananlyzer | Netech Corp. | 1 |
| SigmaPace 1000 | Fluke Electronics Corporation | 1 |
| Analyzer, Pacemaker Generator Function | Boston Scientific Corporation | 1 |
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.