Welch Allyn, Inc.
Welch Allyn PCH-100 Holter Office Software Kit including HR-100 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer
2manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Incote Precision Machinery Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | MLR |
| Device type | Sterilizer, Chemical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6860 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K051730 |
| Record published | 2016-09-17 |
| Record revised | 2022-08-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2022-08-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901052 | In distribution | |
| 901052 | In distribution | |
| 901052 | Withdrawn | |
| 901052 | Withdrawn | |
| 901052 | Withdrawn | |
| 901052 | Withdrawn | |
| 901052 | Withdrawn | |
| 901052 | Withdrawn | |
| 901052 | Withdrawn | |
| 901052 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trilogy® | Zimmer, Inc. | 274 |
| Sterrad™ | Advanced Sterilization Products Services Inc. | 18 |
| NexGen® | Zimmer, Inc. | 15 |
| V-PRO | Steris Mexico, S. de R.L. de C.V. | 7 |
| Amsco V-PRO | Steris Mexico, S. de R.L. de C.V. | 6 |
| SteroScope Insert Connector Large Assembly, Type 3, Qty 1 | Ideate Medical | 4 |
| Vaprox | Steris Corporation | 4 |
| Sterilink™ | Plasmapp Co., Ltd. | 3 |
| SteroScope Insert Connector Extra Small Assembly, Type R2, Qty 1 | Ideate Medical | 2 |
| Sterlink™ | Plasmapp Co., Ltd. | 2 |
| SteroScope Biopsy Connector Assembly, Type R1, Qty 1 | Ideate Medical | 2 |
| Sterrad NX™ | Advanced Sterilization Products Services Inc. | 2 |
Showing 12 of 34. All products under Sterilizer, Chemical
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.