McKesson
Glove, Exam Nitrile Blue CONFIDERM 8.8C PF X-Large 12” CUFF
1manufacturer
7catalogue numbers in this listing
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 |
|---|---|---|---|---|
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | QDA |
| Device type | Electrocardiograph Software For Over-The-Counter Use |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2345 |
| Record published | 2019-10-22 |
| Record revised | 2020-06-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 14-6N82C | 50 | In distribution | |
| 14-6N86C | 50 | In distribution | |
| 14-6N68C | 100 | In distribution | |
| 14-6N62C | 100 | In distribution | |
| 14-6N64C | 100 | In distribution | |
| 14-6N88C | 50 | In distribution | |
| 14-6N84C | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ECG Monitor App | Samsung Electronics Co., Ltd. | 3 |
| ECG 2.0 App | Apple Inc. | 2 |
| ECG App | Apple Inc. | 2 |
| Garmin ECG App | Garmin International, Inc. | 2 |
| Fitbit ECG App | Fitbit LLC | 1 |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 1 |
| Google ECG App | Fitbit LLC | 1 |
| Whoop ECG Feature | Whoop, Inc. | 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.