Medex
41 catalogue numbers from MX048, listed by ICU Medical, Inc, United States, under Tubing, Fluid Delivery. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
41catalogue numbers in this listing
1recall
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 | ICU Medical, Inc, United States |
|---|---|
| FDA product code | FPK |
| Device type | Tubing, Fluid Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-28 |
| Record revised | 2025-04-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 50, case of 25, case of 10, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MX048 | In distribution | |
| MX6251 | In distribution | |
| MX580 | In distribution | |
| MX450SL | In distribution | |
| MX5372 | In distribution | |
| MX448L | In distribution | |
| MX450FL | In distribution | |
| MX43860 | In distribution | |
| MX452 | In distribution | |
| MX20194 | In distribution | |
| MX43660 | In distribution | |
| MX448HL | In distribution | |
| MX43661 | In distribution | |
| MX455FL | In distribution | |
| MX6520 | In distribution | |
| MX456R | In distribution | |
| MX7322SC | In distribution | |
| MX7267 | In distribution | |
| MX451FL | In distribution | |
| MX448HL60 | In distribution | |
| MXG300249 | In distribution | |
| MX7776 | In distribution | |
| MX450FL | In distribution | |
| MX2238 | In distribution | |
| MX458L | In distribution | |
| MX451SL | In distribution | |
| MX456L | In distribution | |
| MX7223SC | In distribution | |
| MX452FL | In distribution | |
| MX456CVL | In distribution | |
| MX7584 | In distribution | |
| MX448L60 | In distribution | |
| MX7512 | In distribution | |
| M20757 | In distribution | |
| MX2800 | In distribution | |
| MX448L36 | In distribution | |
| MX7203 | In distribution | |
| MX448HL36 | In distribution | |
| MX20059 | In distribution | |
| MX448A | In distribution | |
| MX64781 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| High Pressure Tubing | Merit Medical Systems, Inc. | 68 |
| Vygon | Vygon Corp. | 67 |
| 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 |
| EZ-IV | Emed Technologies Corporation | 5 |
Showing 12 of 51. All products under Tubing, Fluid Delivery
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-02-19 | Class II | Process control | Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occ | 48,050 units | 2017-04-24 |
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.