Celerity
Celerity Non-Sterile Disposable (ECG Adhesive Electrodes & Prep Pads)
5manufacturers in China registered for this device type
7catalogue numbers in this listing
16510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), 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 |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Record published | 2015-10-19 |
| Record revised | 2024-03-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature up to 27 °C |
| Packaging | Box of 25 |
| Distribution end date | 2021-05-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H787471450 | In distribution | |
| 47-143 | In distribution | |
| 47-142 | In distribution | |
| H787471460 | In distribution | |
| H787471470 | In distribution | |
| H787471400 | In distribution | |
| H787471440 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163452 | 2017-02-03 |
| K152409 | 2015-09-24 |
| K150527 | 2015-03-31 |
| K150448 | 2015-03-19 |
| K142616 | 2014-10-14 |
| K140266 | 2014-03-05 |
| K133264 | 2013-11-20 |
| K131942 | 2013-07-31 |
| K131038 | 2013-05-09 |
| K122882 | 2012-10-18 |
| K121089 | 2012-08-23 |
| K121990 | 2012-08-03 |
| K111906 | 2011-07-29 |
| K101326 | 2010-09-02 |
| K093366 | 2009-11-24 |
| K091261 | 2009-05-12 |
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.