Portex
1,340 catalogue numbers from 4984-17/27, listed by ICU Medical, Inc, United States, under Anesthesia Conduction Kit. 1 manufacturer in China is registered for this product code.
1manufacturer
1,340catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | CAZ |
| Device type | Anesthesia Conduction Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5140 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K965017 |
| Record published | 2017-01-09 |
| Record revised | 2025-04-17 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, box of 10, carton of 10, pallet of 10, pallet of 6, pallet of 7 |
| Distribution end date | 2020-06-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4984-17/27 | In distribution | |
| 4910N-18 | In distribution | |
| A3701-17 | In distribution | |
| A1586-17 | In distribution | |
| A3147 | In distribution | |
| A2992-25 | In distribution | |
| 4966-27 | In distribution | |
| A4283-18 | In distribution | |
| NEPI-4940PL-17 | In distribution | |
| 4977-20 | In distribution | |
| NEPINLD-15545PL-21 | In distribution | |
| A3702-24 | In distribution | |
| A3779-18/27 | In distribution | |
| NLD-49651P-25 | In distribution | |
| 3717C-20 | In distribution | |
| 49661P-25 | In distribution | |
| A3842-17 | In distribution | |
| NLD20-4786-20 | In distribution | |
| 24-2214-01 | In distribution | |
| 24-2235-01 | In distribution | |
| A3293 | In distribution | |
| A2426-17/27 | In distribution | |
| A4147-20 | In distribution | |
| A4064-22 | In distribution | |
| A3991-25 | In distribution | |
| A2240 | In distribution | |
| 24-3107-01 | In distribution | |
| A4173-25 | In distribution | |
| A3473 | In distribution | |
| 24-2226-01 | In distribution | |
| A1976-17 | In distribution | |
| A4066-22 | In distribution | |
| A4313-17 | In distribution | |
| 24-2203-22 | In distribution | |
| 24-1066-01 | In distribution | |
| 24-1022-64 | In distribution | |
| A3403-22/24 | In distribution | |
| A4080-25 | In distribution | |
| A3669-25 | In distribution | |
| 4966-25 | In distribution | |
| A1999-17 | In distribution | |
| A4311-17/25 | In distribution | |
| A3704-25 | In distribution | |
| A4226-20 | In distribution | |
| 3717-20 | In distribution | |
| A3850-18 | In distribution | |
| NEPI-8284-20 | In distribution | |
| A2690 | In distribution | |
| A4160-18 | In distribution | |
| A2985-25 | In distribution | |
| A2799-22 | In distribution | |
| 24-1341-01 | In distribution | |
| A4175 | In distribution | |
| NEPI-4848-18 | In distribution | |
| A4039-17 | In distribution | |
| NEPI-4948-18 | In distribution | |
| 49691 | In distribution | |
| NEPI-49661-24 | In distribution | |
| A4008-17 | In distribution | |
| 4947B-18 | In distribution | |
| 15545PL-21 | In distribution | |
| 24-3101-22 | In distribution | |
| A4100-17 | In distribution | |
| 4963-20 | In distribution | |
| A3976-20 | In distribution | |
| 24-1323-22 | In distribution | |
| A3060-17 | In distribution | |
| 4848C-17 | In distribution | |
| A4304 | In distribution | |
| A2089-25 | In distribution | |
| A4265-17 | In distribution | |
| A1227-18 | In distribution | |
| 24-2255-01 | In distribution | |
| A3499 | In distribution | |
| A3608-25 | In distribution | |
| A3352-22/25 | In distribution | |
| NLD-15848-20 | In distribution | |
| A4286-25 | In distribution | |
| 24-1203-01 | In distribution | |
| A4277-22 | In distribution | |
| A4057-18 | In distribution | |
| A4124 | In distribution | |
| NEPI-NLD-15249-21 | In distribution | |
| A3588-20 | In distribution | |
| NEPI-8024-20 | In distribution | |
| A4083-22 | In distribution | |
| A3606-22 | In distribution | |
| 4918-16/17 | In distribution | |
| 15646-27 | In distribution | |
| 8284-20 | In distribution | |
| A4151-17/25 | In distribution | |
| A1081 | In distribution | |
| A3505-17 | In distribution | |
| A4166-17/25 | In distribution | |
| A3659-17 | In distribution | |
| X-15548-20 | In distribution | |
| 15548-20 | In distribution | |
| 15815-20 | In distribution | |
| A3870-17 | In distribution | |
| A4111-24 | In distribution | |
| A2514-16 | In distribution | |
| A3731-22 | In distribution | |
| A3785-18 | In distribution | |
| 24-1345-01 | In distribution | |
| A2079-17 | In distribution | |
| A1531-17 | In distribution | |
| A2905-18 | In distribution | |
| 15857-20 | In distribution | |
| A4252-18 | In distribution | |
| A3982-25 | In distribution | |
| A3093-20 | In distribution | |
| X-15597PL-20 | In distribution | |
| 15597-22 | In distribution | |
| 24-1304-22 | In distribution | |
| A4137-22 | In distribution | |
| 4827PL-20 | In distribution | |
| 4795-25 | In distribution | |
| 24-1337-01 | In distribution | |
| A3810-20 | In distribution | |
| A1994-18 | In distribution | |
| 24-1309-01 | In distribution | |
| NLD-15597C-20 | In distribution | |
| A1685-17 | In distribution | |
| A3200 | In distribution | |
| A2614 | In distribution | |
| A3040-22 | In distribution | |
| 15551C-20 | In distribution | |
| 24-1208-01 | In distribution | |
| A4148 | In distribution | |
| A3195-17 | In distribution | |
| 24-3104-01 | In distribution | |
| 24-2231-01 | In distribution | |
| A4106-17 | In distribution | |
| A3812-17 | In distribution | |
| X-15248C-22/25 | In distribution | |
| 4949C-17 | In distribution | |
| A4131 | In distribution | |
| A3444-17/27 | In distribution | |
| A2416-25 | In distribution | |
| A2155-25 | In distribution | |
| A3480-27 | In distribution | |
| 4910-16/17 | In distribution | |
| A3360-20 | In distribution | |
| A3469-17 | In distribution | |
| A3993-25 | In distribution | |
| A2026-17 | In distribution | |
| A3324-20 | In distribution | |
| B974-25 | In distribution | |
| A4264-25/27 | In distribution | |
| NEPI-4942PL-17 | In distribution | |
| A3510 | In distribution | |
| 15753-20 | In distribution | |
| A2921-25 | In distribution | |
| 4979-18 | In distribution | |
| NLD-4804-20 | In distribution | |
| A2629-17 | In distribution | |
| 4948-17 | In distribution | |
| A3533-22 | In distribution | |
| A2744-17/27 | In distribution | |
| 4792-22 | In distribution | |
| A2784-25 | In distribution | |
| A2806-20 | In distribution | |
| A4081 | In distribution | |
| A3899-17 | In distribution | |
| A3717-22 | In distribution | |
| A4012-25 | In distribution | |
| 24-2227-01 | In distribution | |
| 24-2248-01 | In distribution | |
| A3929-18 | In distribution | |
| NLD-15555-20 | In distribution | |
| A3867-18 | In distribution | |
| 4917S-17 | In distribution | |
| A4284 | In distribution | |
| NEPI-4966-27 | In distribution | |
| NLD-15711-20 | In distribution | |
| A2306 | In distribution | |
| A3803-17 | In distribution | |
| A4266-17 | In distribution | |
| 4944-17 | In distribution | |
| A3917-20 | In distribution | |
| A4062-22 | In distribution | |
| A3470-25 | In distribution | |
| A1146-17 | In distribution | |
| 4895CS | In distribution | |
| NEPI-4966-25 | In distribution | |
| A3137-25 | In distribution | |
| NEPI-49662-25 | In distribution | |
| A3537 | In distribution | |
| 4949-17 | In distribution | |
| A3590-18 | In distribution | |
| 4823-20 | In distribution | |
| A2954-22 | In distribution | |
| A3906-17 | In distribution | |
| A1824-22 | In distribution | |
| NEPINLD-49651PL-25 | In distribution | |
| A2896-18 | In distribution | |
| A3152 | In distribution | |
| 4979-20 | In distribution | |
| A3474-17 | In distribution | |
| NEPI-4949C-17 | In distribution | |
| 24-2215-01 | In distribution | |
| 3096-20 | In distribution | |
| 24-1334-22 | In distribution | |
| A3622-20 | In distribution | |
| A4253-22 | In distribution | |
| PDX3159 | In distribution | |
| A3550 | In distribution | |
| 24-2210-01 | In distribution | |
| 4935MG-17 | In distribution | |
| NEPI-4948-17 | In distribution | |
| 4848AC-18 | In distribution | |
| 4826PL-20 | In distribution | |
| 24-1303-22 | In distribution | |
| 24-2232-01 | In distribution | |
| 15711-20 | In distribution | |
| NEPI-NLD-15545-23 | In distribution | |
| A2485-18 | In distribution | |
| A3768-18 | In distribution | |
| A3832-17 | In distribution | |
| A4038-17 | In distribution | |
| 24-2240-01 | In distribution | |
| PDX3158 | In distribution | |
| A2606-22 | In distribution | |
| A3736-22 | In distribution | |
| A3514-25 | In distribution | |
| A4183-17/27 | In distribution | |
| A3643-27 | In distribution | |
| A3642-25 | In distribution | |
| 4950-17 | In distribution | |
| A4187-18 | In distribution | |
| NEPI-NLD-15597-20 | In distribution | |
| A2922-18 | In distribution | |
| A3809 | In distribution | |
| 4935OP-17 | In distribution | |
| 24-2256-01 | In distribution | |
| A4058-25 | In distribution | |
| A1865-18 | In distribution | |
| A2428-17 | In distribution | |
| A3690 | In distribution | |
| 24-2211-01 | In distribution | |
| A1243-25 | In distribution | |
| NEPI-NLD-4792-22 | In distribution | |
| NEPI-NLD-49651-27 | In distribution | |
| A4318 | In distribution | |
| A1532-18 | In distribution | |
| NEPI-NLD-4792-20 | In distribution | |
| A3670 | In distribution | |
| A3911-25 | In distribution | |
| 4795-20 | In distribution | |
| A1666-22 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 508 |
| Halyard | Avanos Medical, Inc. | 422 |
| Avanos | Avanos Medical, Inc. | 315 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 215 |
| Integra® | Integra Pain Management | 181 |
| Epilong | Pajunk Gmbh Medizintechnologie | 79 |
| BD Perisafe, BD Epilor, BD Luer-Lok | Becton, Dickinson AND Company | 44 |
| Temena | Temena GmbH | 44 |
| BD Luer-Lok, BD Glaspak | Becton, Dickinson AND Company | 36 |
| Contiplex® | B. Braun Medical Inc. | 34 |
| Stimulong Sono | Pajunk Gmbh Medizintechnologie | 27 |
| Clint Pharmaceuticals | ICU Medical, Inc | 26 |
Showing 12 of 109. All products under Anesthesia Conduction Kit
Recalls Naming This Product
9 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 | Closed |
|---|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2025-12-19 | Class II | Under Investigation by firm | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery. | 64290 total | |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-12-08 | Class II | Error in labeling | The labeling was missing information on sterilization and prohibition of reuse. | 3420 devices | 2023-08-04 |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-02-28 | Class II | Labeling mix-ups | Cases of Portex Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20. | 100 units. | 2021-09-01 |
| Smiths Medical Asd, Inc. | 510(k) number | 2006-10-27 | Not classified | Other | Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch | 540 units | 2012-05-22 |
| Smiths Medical Asd, Inc. | 510(k) number | 2005-11-17 | Not classified | Other | Tray may contain holes compromising the sterility of the device | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2005-11-17 | Not classified | Other | Tray may contain holes compromising the sterility of the device | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2005-11-17 | Not classified | Other | Tray may contain holes compromising the sterility of the device | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2005-11-17 | Not classified | Other | Tray may contain holes compromising the sterility of the device | 2012-05-08 | |
| Portex, Inc. | 510(k) number | 2003-10-10 | Not classified | Other | Spinal trays labeled as containing a Whitacre 25g x 3.5′ needle actually contain a Quincke 25g x 3.5′ needle. | 2600 units | 2006-05-02 |
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.