Therapak
180ml Collection Cup, Individually Wrapped w/temp strip (CS/100)
6manufacturers in China registered for this device type
33catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| K-MED Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 20 |
| Zhejiang Sorfa Life Science Research Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Xiamen Aquatown Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 5 |
Record
| Listed by | Therapak, LLC, United States |
|---|---|
| FDA product code | MPQ |
| Device type | Container, Specimen, Urine, Drugs Of Abuse, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3260 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-04 |
| Record revised | 2026-03-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-03-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ACSK39448 | 100 | In distribution | |
| ACSK39467 | 100 | In distribution | |
| ACSK40010 | 100 | In distribution | |
| ACSK40005 | 100 | In distribution | |
| ACSK39416 | 500 | In distribution | |
| ACSK40003 | 100 | In distribution | |
| ACSK40056 | 100 | In distribution | |
| ACSK40004 | 100 | In distribution | |
| ACSK40031 | 50 | In distribution | |
| ACSK39468 | 100 | In distribution | |
| ACSK40011 | 48 | In distribution | |
| ACSK39470 | 48 | In distribution | |
| ACSK39473 | 100 | In distribution | |
| ACSK40002 | 50 | In distribution | |
| ACSK39449 | 100 | In distribution | |
| CSTG74829_1 | Withdrawn | ||
| ACSK40010 | Withdrawn | ||
| CSTG74850 | Withdrawn | ||
| ACSK40031 | Withdrawn | ||
| ACSK40002 | Withdrawn | ||
| ACSK39473 | Withdrawn | ||
| ACSK39470 | Withdrawn | ||
| ACSK40011 | Withdrawn | ||
| CSTG74829 | Withdrawn | ||
| ACSK40003 | Withdrawn | ||
| ACSK40004 | Withdrawn | ||
| ACSK40005 | Withdrawn | ||
| ACSK39448 | Withdrawn | ||
| ACSK39467 | Withdrawn | ||
| ACSK39416 | Withdrawn | ||
| ACSK39468 | Withdrawn | ||
| ACSK40056 | Withdrawn | ||
| ACSK39449 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ascend | Alphatec Spine, Inc. | 143 |
| Shark Lumbar Spacer System | Choice Spine, LP | 34 |
| Octane Straight IR | Choice Spine, LP | 7 |
| Medline | Medline Industries, Inc. | 3 |
| Xpeedy | Cura Diagnostics Inc. | 3 |
| Mdhc | Mdhc Life Technologies (Kunshan) Co., Ltd. | 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.