Safe-T-Fill®
SAFE-T-FILL® MicroHematocrit Capillary Tubes, 50 µL; Plastic, Ammonium Heparinized, Red Marking
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Zhejiang Huawei Scientific Instrument Co Ltd | Linhai | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Ram Scientific, United States |
|---|---|
| FDA product code | GHY |
| Device type | Hematocrit, Tube, Rack, Sealer, Holder |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6400 |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2025-12-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight.; Special storage condition: Keep Dry. |
| Packaging | Package of 10 |
| Sizes | Total volume 50 to 68 Microliter |
| Distribution end date | 2025-05-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 06 0525 | Total Volume 68 Microliter | 100 | Withdrawn |
| 06 0508 | Total Volume 50 Microliter | 100 | Withdrawn |
| 06 0507 | Total Volume 50 Microliter | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Marketlab Inc | Marketlab Incorporated | 4 |
| LW Scientific, Inc. | LW Scientific, Inc. | 2 |
| Globe Scientific | Globe Scientific, LLC | 1 |
| CompoSeal Mobilea II | Fresenius Kabi AB | 1 |
| Sealing Putty for hematocrit capillaries | Andreas Hettich Gmbh | 1 |
| 75mm Plastic-crit Plain | Drummond Scientific Co. | 1 |
| Hematocrit capillaries | Andreas Hettich Gmbh | 1 |
| 75mm Hemato-clad Heparinized | Drummond Scientific Co. | 1 |
| 75mm Plastic-crit Heparinized | Drummond Scientific Co. | 1 |
| 75mm Self-Sealing Capillary Tubes | Drummond Scientific Co. | 1 |
| 75mm Hemato-clad Plain | Drummond Scientific Co. | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 2000 |
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 209000 |
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.