Medline
Anti-Reflux VALVE,MEDLINE,10/CS
3manufacturers in China registered for this device type
1catalogue number
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 | Medline Industries, 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 |
| Record published | 2024-02-16 |
| Record revised | 2025-07-11 (version 2) |
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 |
| Storage | Special storage condition: Store at room temperature |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ENT70620 | 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 |
| Axiom® Sump-n-Sheath® | Axiom Medical, Inc. | 3 |
Showing 12 of 24. All products under Tube, Double Lumen For Intestinal Decompression And/Or Intubation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132314 | 2013-09-18 |
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.