Axiom® Sump-n-Sheath®
Sump-n-Sheath®, Sump Drain, Three Lumens, Silicone, Large Eye, With Silicone Penrose, With Suture Ring
3manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Record
| Listed by | Axiom Medical, Inc., United States |
|---|---|
| FDA product code | FEG |
| Device type | Tube, Double Lumen For Intestinal Decompression And/Or Intubation |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Manufacturer |
| 510(k) | K771048 |
| Record published | 2018-09-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, box of 10 |
| Sizes | Lumen/inner diameter 0.5 to 0.625 in; length 14 to 20 in; lumen/inner diameter 7 to 9 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 111156 | Lumen/Inner Diameter 0.5 in | In distribution |
| 111155 | Lumen/Inner Diameter 0.625 in | In distribution |
| 111157 | Lumen/Inner Diameter 0.625 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salem Sump | Cardinal Health 200, LLC | 30 |
| Salem Sump | Cardinal Health | 18 |
| Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter | C.R. Bard, Inc. | 14 |
| Axiom® Dual-Sump | Axiom Medical, Inc. | 9 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Axiom® Uni-Sump | Axiom Medical, Inc. | 7 |
| Bard® Nasogastric Sump Tube and PreVent® Filter and Lopez Valve® with ENFit™ | C.R. Bard, Inc. | 6 |
| Bilbao Dotter | Cook Incorporated | 4 |
| Nasogastric Sump Tube with PreVent® Anti-Reflux Filter And Lopez Valve® | C.R. Bard, Inc. | 4 |
| Kangaroo | Cardinal Health | 3 |
| Marcon | Cook Ireland Ltd | 3 |
| Maglinte | Cook Incorporated | 2 |
Showing 12 of 24. All products under Tube, Double Lumen For Intestinal Decompression And/Or Intubation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K771048 | 1977-07-19 |
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.