Medline Industries, Inc.
Bone Recovery PK A&B Accessory
79manufacturers in China registered for this device type
103catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (29), Zhejiang (24), Guangdong (8). 13 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 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Shanghai Huayue Packaging Products Co., Ltd. | Fengxian District | Shanghai | Contract manufacturer | 18 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 79. All 79 manufacturers in China registered for Container, Specimen, Sterile
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FMH |
| Device type | Container, Specimen, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Premarket notification | Exempt |
| Record published | 2024-08-11 |
| Record revised | 2023-04-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 4, case of 2, case of 3, case of 20, case of 50, case of 30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJ87979 | In distribution | |
| DYNJ85147 | In distribution | |
| DYNJ909900A | In distribution | |
| DYNJ81740B | In distribution | |
| P828114 | In distribution | |
| DYNJ87320 | In distribution | |
| DYNJT4016 | In distribution | |
| DYNJ85884 | In distribution | |
| DYNJ85447 | In distribution | |
| DYNJ64671A | In distribution | |
| DYNJ84531 | In distribution | |
| DYNJ37313S | In distribution | |
| DYNJ86380 | In distribution | |
| DYNJ62358A | In distribution | |
| DYNJ69232B | In distribution | |
| DYNJ909899 | In distribution | |
| DYNJ84041 | In distribution | |
| DYNJ909900 | In distribution | |
| DYNJ81739A | In distribution | |
| DYNJ908848B | In distribution | |
| DYNJSJAR | In distribution | |
| DYNJ66691B | In distribution | |
| DYNJ64058A | In distribution | |
| DYNJ64443C | In distribution | |
| DYNJ87231 | In distribution | |
| DYNJ85885 | In distribution | |
| DYNJ87813 | In distribution | |
| DYNJ81739 | In distribution | |
| DYNJ87318 | In distribution | |
| DYNJ64673B | In distribution | |
| DYNJ85775B | In distribution | |
| DYNDA1715 | In distribution | |
| DYNJ62190B | In distribution | |
| DYNJ908848A | In distribution | |
| DYNJT3762 | In distribution | |
| DYNJ87650 | In distribution | |
| DYNJ63118A | In distribution | |
| DYNJ62358B | In distribution | |
| DYNJ82213A | In distribution | |
| DYNJ63438A | In distribution | |
| DYNJGUIDEWIRE | In distribution | |
| DYNJ66591C | In distribution | |
| DYNJ67549C | In distribution | |
| DYNJ908848 | In distribution | |
| DYNJ63535A | In distribution | |
| DYNJ37313R | In distribution | |
| DYNJ68151B | In distribution | |
| DYNJ69805A | In distribution | |
| DYNJ49798K | In distribution | |
| DYNJ87758 | In distribution | |
| DYNJ55959F | In distribution | |
| DYNJ62190A | In distribution | |
| DYNJ62715A | In distribution | |
| DYNJ81861 | In distribution | |
| DYNJ69146A | In distribution | |
| DYNJ905664I | In distribution | |
| DYNJ82155 | In distribution | |
| DYNJ81738A | In distribution | |
| DYNJ64058B | In distribution | |
| DYLAB1022 | In distribution | |
| DYNJ86300 | In distribution | |
| DYNJ50241C | In distribution | |
| DYNJ61179A | In distribution | |
| DYNJ58575D | In distribution | |
| DYNJ85880 | In distribution | |
| DYNJ9861989O | In distribution | |
| DYNJ81740A | In distribution | |
| DYNJ66591B | In distribution | |
| DYNJ87758A | In distribution | |
| DYNJ87980 | In distribution | |
| DYNJ68149B | In distribution | |
| DYNJ85784 | In distribution | |
| DYNJ85784A | In distribution | |
| DYNJ85886 | In distribution | |
| DYNJ81738 | In distribution | |
| DYNJ81740 | In distribution | |
| DYNJ58575C | In distribution | |
| DYNJ68147B | In distribution | |
| DYNJ58348C | In distribution | |
| DYNJ85191 | In distribution | |
| DYNJ57830A | In distribution | |
| DYNJ68147C | In distribution | |
| DYNJ86379 | In distribution | |
| DYNJ65728A | In distribution | |
| DYNJ89539 | In distribution | |
| DYNJ909997A | In distribution | |
| DYNJ68900A | In distribution | |
| DYNJ50240B | In distribution | |
| DYNJ64673A | In distribution | |
| DYNJ81928 | In distribution | |
| DYNJ82155A | In distribution | |
| DYNJ57828B | In distribution | |
| DYNJ55826A | In distribution | |
| DYNJ68205B | In distribution | |
| DYNJ81738B | In distribution | |
| DYNJ909899A | In distribution | |
| DYNJ87319 | In distribution | |
| DYNJ81738C | In distribution | |
| DYNJ87978 | In distribution | |
| DYNJ81740C | In distribution | |
| DYNJ68205A | In distribution | |
| DYNJ55992B | In distribution | |
| DYNJ85192 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Corning® | Corning Incorporated | 49 |
| Cardinal Health | Cardinal Health 200, LLC | 42 |
| Medline | Medline Industries, Inc. | 41 |
| Bioseal Inc. | Bioseal | 37 |
| Centurion | Centurion Medical Products Corporation | 29 |
| Globe Scientific | Globe Scientific, LLC | 29 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 27 |
| Sterile Specimen Container | Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V. | 20 |
| Vacuette | Greiner BIO-ONE Gmbh | 19 |
| Precision | Cardinal Health | 15 |
| Dover | Cardinal Health | 14 |
| Samco Clicktainer | Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V. | 14 |
Showing 12 of 182. All products under Container, Specimen, Sterile
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 380 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 72 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 117907 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 160980 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 72 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-11 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. | 14589 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 159 cases (159 units) |
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.