AccuFlo
92" IV Set w/ IV Flow Regulator with a needle free site
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Emed Technologies Corporation, United States |
|---|---|
| FDA product code | FPK |
| Device type | Tubing, Fluid Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K935642 |
| Record published | 2016-09-23 |
| Record revised | 2021-04-07 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -5 to 40 °C |
| Distribution end date | 2016-09-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FLO-100 | 50 | In distribution | |
| FLO-120 | 50 | In distribution | |
| FLO-110 | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| High Pressure Tubing | Merit Medical Systems, Inc. | 68 |
| Vygon | Vygon Corp. | 67 |
| Medex | ICU Medical, Inc | 41 |
| High Pressure Tubing, Keep™ | Merit Medical Systems, Inc. | 25 |
| Pressure Monitor Tubing | Merit Medical Systems, Inc. | 21 |
| Medrad® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) | Bayer Medical Care Inc. | 16 |
| Merit Medical® | Merit Medical Systems, Inc. | 10 |
| Kew Medical | Douglas Medical Products, Inc | 8 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 5 |
| CIV | Emed Technologies Corporation | 5 |
| Medrad® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube | Bayer Medical Care Inc. | 5 |
| Lifeshield | ICU Medical, Inc | 5 |
Showing 12 of 51. All products under Tubing, Fluid Delivery
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Kimberly-Clark Corporation | 510(k) number | 2006-03-15 | Not classified | Other | There exists a possibility that the Pain Management Procedural Trays may contain extension sets that do not meet USP specification requirements for non pyrogenicity (less than or equal to 2.25 EU/device (Endotoxin Units/device). | 925 each | 2011-05-10 |
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.