Argyle
I.V. Support Board,Preemie
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | BTX |
| Device type | Board, Arm (With Cover), Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-30 |
| Record revised | 2023-07-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 50 |
| Sizes | Width 1 to 1.875 in; length 3 to 4.875 in |
| Distribution end date | 2023-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MI00880 | Width 1 in | Withdrawn |
| MI00775 | Length 3.875 in | Withdrawn |
| MI00850 | Width 1.875 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Argyle | Cardinal Health 200, LLC | 3 |
| Voss Laminectomy Harness | VM/Positioning, Inc. | 1 |
| Medtronic | Quantum OPS 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.