ICU Medical
Oncology Kit w/31" (79 cm) Appx 3.5 ml, Admin Set w/20 Drop Integrated ChemoClave™ Drip Chamber, Spiros™; Locking Universal Vented Vial Spike, ChemoClave™; Spinning Spiros™; Red Cap; Bag…
Oncology Kit w/31″ (79 cm) Appx 3.5 ml, Admin Set w/20 Drop Integrated ChemoClave™ Drip Chamber, Spiros™; Locking Universal Vented Vial Spike, ChemoClave™; Spinning Spiros™; Red Cap; Bag Hanger
1manufacturer
255catalogue numbers in this listing
4510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | ONB |
| Device type | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K131549 |
| Record published | 2021-07-27 |
| Record revised | 2021-04-07 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50, pack of 50, case of 25, box of 50, pack of 25, case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CL-35 | In distribution | |
| CL3947 | In distribution | |
| CL-76S | In distribution | |
| CL-62T | In distribution | |
| CL4143 | In distribution | |
| AHCL3300 | In distribution | |
| CL3940 | In distribution | |
| CL3535 | In distribution | |
| CL-13-5 | In distribution | |
| CL2150 | In distribution | |
| CL4193 | In distribution | |
| CH-70SL | In distribution | |
| CL4145 | In distribution | |
| CL-80-10T | In distribution | |
| CL3520 | In distribution | |
| CL2100-5 | In distribution | |
| CH3959 | In distribution | |
| CL4151 | In distribution | |
| CH-12 | In distribution | |
| CL3941 | In distribution | |
| CL-12T | In distribution | |
| CL-75S | In distribution | |
| CL-10-5 | In distribution | |
| CL-13-10T | In distribution | |
| CH4001 | In distribution | |
| CL3511T | In distribution | |
| CL2000S-PC | In distribution | |
| CL-80T | In distribution | |
| CL-51 | In distribution | |
| CL4190 | In distribution | |
| CL2005 | In distribution | |
| CL-80-5 | In distribution | |
| CL3020T | In distribution | |
| AHCL2000S | In distribution | |
| CH3034 | In distribution | |
| CH3673 | In distribution | |
| CL-51-10 | In distribution | |
| CL-70-10T | In distribution | |
| CL-80S-5 | In distribution | |
| CL4176 | In distribution | |
| CL3361 | In distribution | |
| AHCL-10 | In distribution | |
| CL-13-10 | In distribution | |
| CL-70S-5 | In distribution | |
| CL3511-5 | In distribution | |
| CL-85S | In distribution | |
| CH3564 | In distribution | |
| CL-72 | In distribution | |
| CL-10-10 | In distribution | |
| CL4161 | In distribution | |
| CL-70S | In distribution | |
| CL3940-5 | In distribution | |
| CL-80ST | In distribution | |
| CH-14 | In distribution | |
| CL4146-5 | In distribution | |
| CL2060 | In distribution | |
| CL3964 | In distribution | |
| CL4163 | In distribution | |
| CL3927 | In distribution | |
| CL3982 | In distribution | |
| CH3033 | In distribution | |
| CL2000ST | In distribution | |
| CL4168 | In distribution | |
| CL-76 | In distribution | |
| CL4160 | In distribution | |
| CL4114 | In distribution | |
| CL3536 | In distribution | |
| CL3959 | In distribution | |
| CL3364 | In distribution | |
| CL2100T | In distribution | |
| CH3710 | In distribution | |
| CL-13U | In distribution | |
| CL-17 | In distribution | |
| CL-14-10T | In distribution | |
| CL3952 | In distribution | |
| CL2000S-5 | In distribution | |
| CH-70S | In distribution | |
| CL3946 | In distribution | |
| CL6000 | In distribution | |
| CL3934 | In distribution | |
| CL4139 | In distribution | |
| CL4177 | In distribution | |
| CL3538 | In distribution | |
| CH-70 | In distribution | |
| CH3128 | In distribution | |
| CL3511 | In distribution | |
| CL3931 | In distribution | |
| CL2000S-10 | In distribution | |
| CL6000-5 | In distribution | |
| CL4131 | In distribution | |
| CL2000SCPT | In distribution | |
| CH2060 | In distribution | |
| CH2020 | In distribution | |
| CH2000S | In distribution | |
| CH3763 | In distribution | |
| CL-80-9 | In distribution | |
| CH-62 | In distribution | |
| CL-17T | In distribution | |
| CL3994 | In distribution | |
| CH-85S | In distribution | |
| CL3028 | In distribution | |
| CL3528 | In distribution | |
| CL3948 | In distribution | |
| CL-51T | In distribution | |
| CH-17 | In distribution | |
| CL4165 | In distribution | |
| CL-82 | In distribution | |
| CL4153 | In distribution | |
| CL-14 | In distribution | |
| CL3963 | In distribution | |
| CL3974 | In distribution | |
| CL2000S | In distribution | |
| CL4130 | In distribution | |
| CL3028T | In distribution | |
| CL3932T | In distribution | |
| CL4173 | In distribution | |
| CL-12 | In distribution | |
| CH3494 | In distribution | |
| CL2000S-RC | In distribution | |
| CL4167 | In distribution | |
| CL4120 | In distribution | |
| CL3969 | In distribution | |
| CL3962 | In distribution | |
| CL-70T | In distribution | |
| CL3534 | In distribution | |
| CL-10T | In distribution | |
| CL4170 | In distribution | |
| CL3933 | In distribution | |
| CL3960T | In distribution | |
| CL-80S-10T | In distribution | |
| CL-13T | In distribution | |
| SL3534 | In distribution | |
| CL2010 | In distribution | |
| CL4164 | In distribution | |
| CL-70SLT | In distribution | |
| CL3528T | In distribution | |
| CL-84 | In distribution | |
| CL-70ST | In distribution | |
| CH6001 | In distribution | |
| CL3932 | In distribution | |
| CL-34T | In distribution | |
| CL3995 | In distribution | |
| CH3760 | In distribution | |
| CL3286 | In distribution | |
| CL3534T | In distribution | |
| CL3534U | In distribution | |
| CL4172 | In distribution | |
| CH-75S | In distribution | |
| CH2030 | In distribution | |
| CH-10 | In distribution | |
| CL4180 | In distribution | |
| CL4116T | In distribution | |
| CL-63 | In distribution | |
| CH2010 | In distribution | |
| CH3703 | In distribution | |
| CL2030 | In distribution | |
| CL3930 | In distribution | |
| CL3955 | In distribution | |
| CH3769 | In distribution | |
| CL-70SL | In distribution | |
| CL3967 | In distribution | |
| CL3960 | In distribution | |
| CL4159 | In distribution | |
| CH4130 | In distribution | |
| CL-72T | In distribution | |
| CH3637 | In distribution | |
| CL-72-10 | In distribution | |
| CL3340 | In distribution | |
| CL-70-10 | In distribution | |
| CL4181 | In distribution | |
| CH-13 | In distribution | |
| CL-21 | In distribution | |
| CL3958 | In distribution | |
| CL4171 | In distribution | |
| CL4000 | In distribution | |
| CL3360 | In distribution | |
| CL2020 | In distribution | |
| CL-13 | In distribution | |
| CH2000 | In distribution | |
| CL-15 | In distribution | |
| CL4179 | In distribution | |
| CH3198 | In distribution | |
| CL3975 | In distribution | |
| CL3535T | In distribution | |
| AHCL-80 | In distribution | |
| CL4185 | In distribution | |
| CH-80 | In distribution | |
| CH-12-C | In distribution | |
| CL4166 | In distribution | |
| CL3978 | In distribution | |
| CH3955 | In distribution | |
| CL4141 | In distribution | |
| CL-80S-10 | In distribution | |
| CL-12-5 | In distribution | |
| CL3990 | In distribution | |
| CL6001 | In distribution | |
| CL-84S | In distribution | |
| AHCL-70 | In distribution | |
| CL3011T | In distribution | |
| CL3938 | In distribution | |
| CH3011 | In distribution | |
| CH3900 | In distribution | |
| CL3940T | In distribution | |
| CL3935 | In distribution | |
| CL-80SL | In distribution | |
| CL4169 | In distribution | |
| CL-82T | In distribution | |
| CL3020 | In distribution | |
| CL3294 | In distribution | |
| CL3956 | In distribution | |
| CH2003 | In distribution | |
| CL3955T | In distribution | |
| CL4130-5 | In distribution | |
| CH4002 | In distribution | |
| CL3900T | In distribution | |
| AHCL2100 | In distribution | |
| CL2000T | In distribution | |
| CL3966 | In distribution | |
| CL4106 | In distribution | |
| CL2201 | In distribution | |
| CL-70 | In distribution | |
| CL2003 | In distribution | |
| CL3968 | In distribution | |
| CL-33T | In distribution | |
| CL-80 | In distribution | |
| CL4136 | In distribution | |
| CL-62 | In distribution | |
| CL3967T | In distribution | |
| CL4175 | In distribution | |
| CL2050 | In distribution | |
| CH2050 | In distribution | |
| CL4116 | In distribution | |
| CL2000S-10T | In distribution | |
| CH-80S | In distribution | |
| CH3147 | In distribution | |
| CH2005 | In distribution | |
| CL4100 | In distribution | |
| CL4174 | In distribution | |
| CL-10 | In distribution | |
| CH3020 | In distribution | |
| CL4138 | In distribution | |
| CL-80SLT | In distribution | |
| CL-14-10 | In distribution | |
| CL-80S | In distribution | |
| CL-70-5 | In distribution | |
| CL-80S-4 | In distribution | |
| CLH-12 | In distribution | |
| CL4182 | In distribution | |
| CL-33 | In distribution | |
| CL4110 | In distribution |
Showing 250 of 255 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equashield | Equashield Medical Ltd | 83 |
| BD PhaSeal | BD Switzerland Sàrl | 23 |
| Halo | J & J Solutions, Inc. | 14 |
| ProSeal Cstd | Epic International (Thailand) Co., Ltd. | 12 |
| BD PhaSeal Optima | BD Switzerland Sàrl | 11 |
| Equashield Cstd | Equashield Medical Ltd | 6 |
| Luer Lock Adaptor 2 Swivel A | Equashield Medical Ltd | 1 |
| ICU Medical, Inc. | ICU Medical, Inc | 1 |
| OnGuard®2 Cstd Luer Lock Adaptor | Simplivia Healthcare Ltd. | 1 |
| OnGuard2 Syringe Adaptor, 5 Units | Simplivia Healthcare Ltd. | 1 |
| OnGuard 2 Cstd Bag Adaptor LL with Ultrasite | Simplivia Healthcare Ltd. | 1 |
| Tevadaptor Catheter Adaptor | Simplivia Healthcare Ltd. | 1 |
Showing 12 of 60. All products under Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190157 | 2019-10-23 |
| K173477 | 2018-08-31 |
| K170110 | 2018-08-10 |
| K131549 | 2013-07-26 |
Recalls Naming This Product
65 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2026-05-12 | Not classified | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, | 28,550 |
| ICU Medical, Inc | 510(k) number | 2026-05-12 | Not classified | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and | 6,105,468 |
| ICU Medical, Inc | 510(k) number | 2026-03-24 | Class II | Process control | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential f | 20,506 |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 875 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 2100 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 2000 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 200 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 11000 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 7950 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 1100 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 3000 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 150 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 600 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 950 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 200 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 200 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 7850 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 4000 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 16850 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 11200 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 9004 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 6150 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 53,050 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 8475 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 3350 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 133,255 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 950 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 1700 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 6450 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 80 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 400 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 900 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 2000 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 2450 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 11000 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 5700 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 1600 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 200 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 134700 units |
| ICU Medical, Inc | 510(k) number | 2025-09-08 | Class II | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | 134,700 units |
Showing 40 of 65.
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.