Halyard
HALYARD* Lubricating Deodorant Clear Unscented .25 oz.
7manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang | Shandong | Manufacturer | 23 |
| Zhejiang Ailebao Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 11 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
| Pinghu Sama Medical Packing Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 4 |
Record
| Listed by | O&M Halyard, Inc., United States |
|---|---|
| FDA product code | GDS |
| Device type | Bag, Stomal |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-11-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12, case of 400 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55645 | In distribution | |
| 55658 | In distribution | |
| 55644 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hollister | Hollister Incorporated | 9 |
| OstomyGel | DMC Importacao E Exportacao DE Equipamentos Ltda | 1 |
| Stryker Fecal Management System | Sage Products LLC | 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.