RMS Precision Flow Rate TubingTM
High Flow Rate Kit (2 x F275, 5 x F600, 5 x F900, 4 x F1200, 4 x F2400)
5manufacturers in China registered for this device type
24catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Repro-Med Systems, Inc., United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| 510(k) | K933652 |
| Record published | 2016-08-19 |
| Record revised | 2024-04-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature; Storage environment temperature 16 to 30 °C |
| Packaging | Carton of 50 |
| Sizes | Lumen/inner diameter 0.004 to 0.033 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F275 | Lumen/Inner Diameter 0.014 in | In distribution |
| F2 | Lumen/Inner Diameter 0.006 in | In distribution |
| F3.8 | Lumen/Inner Diameter 0.006 in | In distribution |
| H20KT | In distribution | |
| F60 | Lumen/Inner Diameter 0.012 in | In distribution |
| F45 | Lumen/Inner Diameter 0.01 in | In distribution |
| F180 | Lumen/Inner Diameter 0.014 in | In distribution |
| F2400 | Lumen/Inner Diameter 0.022 in | In distribution |
| L20KT | In distribution | |
| F8 | Lumen/Inner Diameter 0.006 in | In distribution |
| F15 | Lumen/Inner Diameter 0.0084 in | In distribution |
| F0.5 | Lumen/Inner Diameter 0.004 in | In distribution |
| F10 | Lumen/Inner Diameter 0.0084 in | In distribution |
| F600 | Lumen/Inner Diameter 0.014 in | In distribution |
| F1200 | Lumen/Inner Diameter 0.014 in | In distribution |
| F900 | Lumen/Inner Diameter 0.014 in | In distribution |
| F5 | Lumen/Inner Diameter 0.006 in | In distribution |
| F120 | Lumen/Inner Diameter 0.014 in | In distribution |
| F1 | Lumen/Inner Diameter 0.004 in | In distribution |
| F3 | Lumen/Inner Diameter 0.006 in | In distribution |
| F420 | Lumen/Inner Diameter 0.014 in | In distribution |
| VHF | Lumen/Inner Diameter 0.033 in | In distribution |
| F30 | Lumen/Inner Diameter 0.01 in | In distribution |
| F500 | Lumen/Inner Diameter 0.014 in | 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 |
| 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 |
| Plum | ICU Medical, Inc | 14 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K933652 | 1994-05-18 |
| K844401 | 1985-03-12 |
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 | Closed |
|---|---|---|---|---|---|---|
| Repro-Med Systems, Inc. | 510(k) number | 2016-03-10 | Class II | Nonconforming Material/Component | On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part numb | 2018-02-26 |
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.