Convertors
Vi-Drape Isolation Bag
4manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Aoki Medical Dressing Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Xiamen JPL Industry & Trade Co., Ltd. | Xiang An Area, Xiamen | Fujian | Manufacturer | 2 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | KGY |
| Device type | Bag, Intestine |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4100 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-06-30 |
| Record revised | 2025-07-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 40, case of 10 |
| Distribution end date | 2028-03-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| D5510 | In distribution | ||
| D5510 | In distribution | ||
| D5510NS | 100 | In distribution | |
| D1003 | In distribution | ||
| D1003NS | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LapSac | Cook Incorporated | 12 |
| LapSac | Coopersurgical, Inc. | 4 |
| P&P Medical Surgical LLC | P&P Medical Surgical LLC | 4 |
| Ultimate Endo retrieval pouch | Purple Surgical International Limited | 3 |
| Weck | Teleflex Medical LLC | 3 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2 |
| 3M™ Steri-Drape™ | 3M Company | 2 |
| Secqure Ultimate | Secqure Surgical, Corp. | 2 |
| Medline-Microtek | Microtek Medical LLC | 2 |
| Cardinal Health | Cardinal Health 200, LLC | 1 |
| Halyard | Owens & Minor Distribution, Inc. | 1 |
| Cardinal Health | Microtek Medical LLC | 1 |
Showing 12 of 20. All products under Bag, Intestine
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.