Stradis Medical, LLC.
Pen Needle Kit
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | PQD |
| Device type | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1675 |
| Record published | 2020-03-25 |
| Record revised | 2021-04-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Outer box of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 511390 | In distribution | |
| 511389 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Everlywell Blood Collection Kit | Everly Health, Inc. | 12 |
| Tasso+ Convenience Kit | Tasso Inc | 12 |
| Aero-Med | Aero-MED LLC | 9 |
| Cue Sample Collection Kit | Cue Health, Inc. | 5 |
| Zinzino | RDA Spot, UAB | 5 |
| RDA Spot | RDA Spot, UAB | 4 |
| Bloodo | RDA Spot, UAB | 4 |
| Stradis Healthcare | Stradis Healthcare | 3 |
| Everlywell Blood and Saliva Collection Kit | Everly Health, Inc. | 2 |
| Progen PRP Eclipse | Bellus Medical, LLC | 2 |
| Stradis | Stradis Healthcare | 2 |
| Cardinal Health | Cardinal Health 200, LLC | 2 |
Showing 12 of 79. All products under Blood Specimen Collection Convenience Kit (Excludes Hiv)
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.