ambIT* Continuous Pump
Continuous Pump
5manufacturers in China registered for this device type
1catalogue number
6recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K033325 |
| Record published | 2022-02-07 |
| Record revised | 2024-08-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 220244 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Sorenson Medical, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour. | 3460 units | 2011-05-26 |
| Sorenson Medical, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour. | 30,697 units | 2011-05-26 |
| Sorenson Medical, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour. | 2000 units | 2011-05-26 |
| Sorenson Medical, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour. | 4956 units | 2011-05-26 |
Recalls
5 of these are 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 |
|---|---|---|---|---|---|
| 2023-04-24 | Class II | Under Investigation by firm | Some of the ambIT kits were potentially distributed without an air in-line filter. | 33 cases (165 cassettes) | 2024-08-02 |
| 2023-04-24 | Class II | Under Investigation by firm | Some of the ambIT kits were potentially distributed without an air in-line filter. | 57 cases (285 cassettes) | 2024-08-02 |
| 2023-04-24 | Class II | Under Investigation by firm | Some of the ambIT kits were potentially distributed without an air in-line filter. | 40 cases (200 cassettes) | 2024-08-02 |
| 2023-04-24 | Class II | Under Investigation by firm | Some of the ambIT kits were potentially distributed without an air in-line filter. | 45 cases (225 cassettes) | 2024-08-02 |
| 2023-04-24 | Class II | Under Investigation by firm | Some of the ambIT kits were potentially distributed without an air in-line filter. | 1155 total, 280 individually packaged | 2024-08-02 |
| 2003-03-05 | Not classified | Other | Wrong component may result in over infusion of medications. | 5,808 units | 2004-12-01 |
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.