CompressAR Elliptical Comfort Disc
The CompressAR Oval (Elliptical) Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis.…
The CompressAR Oval (Elliptical) Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5197 is an oval (ellliptical) disc with upturned edges (1.75” x 2.5″).
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Semler Technologies, Inc., United States |
|---|---|
| FDA product code | DWS |
| Device type | Instruments, Surgical, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| 510(k) | K891000 |
| Record published | 2016-09-24 |
| Record revised | 2024-10-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 12, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5197 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Delacroix-Chevalier | Landanger | 1,819 |
| Landanger | Landanger | 1,213 |
| Ambler Surgical | Ambler Surgical, LLC | 1,013 |
| Pilling | Teleflex Medical LLC | 971 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 876 |
| V. Mueller | Steris Corporation | 716 |
| Novo Surgical | Novo Surgical, Inc. | 387 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 364 |
| Instruments, Surgical, Cardiovascular | Fehling Instruments GmbH | 352 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 290 |
| Avalign | Avalign Technologies, Inc. | 283 |
| Millennium | Avalign Technologies, Inc. | 272 |
Showing 12 of 472. All products under Instruments, Surgical, Cardiovascular
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.