Coflex NL
CoFlex NL Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap KIDSPACK 2"X5 Yds
280manufacturers in China registered for this device type
12catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (85), Zhejiang (75), Guangdong (29). 38 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 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
Showing 12 of 280. All 280 manufacturers in China registered for Bandage, Elastic
Record
| Listed by | Andover Healthcare, Inc., United States |
|---|---|
| FDA product code | FQM |
| Device type | Bandage, Elastic |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5075 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 77 °F |
| Packaging | Case of 36, case of 24, case of 18, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KIDSPACK 2″ X 5 Yds | In distribution | |
| CPK, 1″X5Yds | In distribution | |
| BLUE 3″ X 5 Yds | In distribution | |
| KIDSPACK 3″X5YD | In distribution | |
| BLUE, 4″ X 5 Yds | In distribution | |
| TAN, 3″ X 5 Yds | In distribution | |
| TAN, 4″ X 5 Yds | In distribution | |
| CPK, 3″ X 5 Yds | In distribution | |
| CPK, 4″ X 5 Yds | In distribution | |
| TAN, 1″X5Yds | In distribution | |
| CPK, 2″X5Yds | In distribution | |
| TAN 2″ X 5Yds | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 194 |
| MT Spandage | Medi-Tech, Inc. | 107 |
| Tronex International, Inc. | Tronex International, Inc. | 79 |
| Bioseal Inc. | Bioseal | 57 |
| Medline | Medline Industries, Inc. | 56 |
| 3M™ Coban™ | 3M Company | 52 |
| Sensi-Wrap, Self Adherent | Dynarex Corp. | 49 |
| Cardinal Health | Cardinal Health 200, LLC | 49 |
| Bandage, Elastic | Tetra Medical Supply Corp. | 48 |
| PremierPro | Prestige Ameritech | 48 |
| Co-Ease | Hemasource | 45 |
| CotZee | Hemasource | 44 |
Showing 12 of 345. All products under Bandage, Elastic
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-04-02 | Class II | Process control | A packaging seal gap could impact the sterility of the product. | 108 cases (1,944 individual product packages) | |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 1798 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 330 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 1759 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 269 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 1050 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 8500 Cases | 2020-09-09 |
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.