Jelco
GTIN for PROTECTIVE W SAFETY IV CATHETER - RADIOPAQUE 20G 1/EA
12manufacturers in China registered for this device type
104catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Foshan Special Medical Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | FOZ |
| Device type | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K113700 |
| Record published | 2016-10-05 |
| Record revised | 2025-04-24 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 50, carton of 200, carton of 4, box of 200, bag of 50, bag of 4 |
| Distribution end date | 2020-08-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 405311 | In distribution | |
| 3066 | In distribution | |
| 448811 | In distribution | |
| 505011 | In distribution | |
| 405011 | In distribution | |
| 305006 | In distribution | |
| 442511 | In distribution | |
| 505611 | In distribution | |
| 449211 | In distribution | |
| 442711 | In distribution | |
| 326800 | In distribution | |
| 3267 | In distribution | |
| 3055 | In distribution | |
| 504211 | In distribution | |
| 326600 | In distribution | |
| 407200 | In distribution | |
| 3265 | In distribution | |
| 335503 | In distribution | |
| 339601 | In distribution | |
| 328700 | In distribution | |
| 3076 | In distribution | |
| 3266 | In distribution | |
| 505311 | In distribution | |
| 306501 | In distribution | |
| 505511 | In distribution | |
| 3072 | In distribution | |
| 405511 | In distribution | |
| 442611 | In distribution | |
| 339501 | In distribution | |
| 405411 | In distribution | |
| 3060 | In distribution | |
| 3075 | In distribution | |
| 3073 | In distribution | |
| 3067 | In distribution | |
| 328500 | In distribution | |
| 3056 | In distribution | |
| 328000 | In distribution | |
| 408811 | In distribution | |
| 407300 | In distribution | |
| 335903 | In distribution | |
| 449811 | In distribution | |
| 508811 | In distribution | |
| 306801 | In distribution | |
| 3263 | In distribution | |
| 3077 | In distribution | |
| 442011 | In distribution | |
| 405611 | In distribution | |
| 308600 | In distribution | |
| 3088 | In distribution | |
| 405711 | In distribution | |
| 442411 | In distribution | |
| 446611 | In distribution | |
| 305706 | In distribution | |
| 335703 | In distribution | |
| 335603 | In distribution | |
| 3063 | In distribution | |
| 3268 | In distribution | |
| 505711 | In distribution | |
| 335800 | In distribution | |
| 326300 | In distribution | |
| 404811 | In distribution | |
| 335003 | In distribution | |
| 326000 | In distribution | |
| 3080 | In distribution | |
| 328200 | In distribution | |
| 326500 | In distribution | |
| 504811 | In distribution | |
| 326700 | In distribution | |
| 338300 | In distribution | |
| 508211 | In distribution | |
| 335304 | In distribution | |
| 326200 | In distribution | |
| 446711 | In distribution | |
| 3070 | In distribution | |
| 441811 | In distribution | |
| 407000 | In distribution | |
| 3082 | In distribution | |
| 306201 | In distribution | |
| 3262 | In distribution | |
| 446511 | In distribution | |
| 446411 | In distribution | |
| 446111 | In distribution | |
| 305306 | In distribution | |
| 328300 | In distribution | |
| 338001 | In distribution | |
| 3078 | In distribution | |
| 448211 | In distribution | |
| 328800 | In distribution | |
| 404211 | In distribution | |
| 337300 | In distribution | |
| 3083 | In distribution | |
| 328600 | In distribution | |
| 441211 | In distribution | |
| 3048 | In distribution | |
| 407500 | In distribution | |
| 308700 | In distribution | |
| 3085 | In distribution | |
| 335200 | In distribution | |
| 335403 | In distribution | |
| 405911 | In distribution | |
| 408211 | In distribution | |
| 3260 | In distribution | |
| 407600 | Withdrawn | |
| 407800 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 2,368 |
| Cook | Cook Incorporated | 250 |
| Cook Spectrum | Cook Incorporated | 225 |
| Medline | Medline Industries, Inc. | 95 |
| Deltaven Fast Flash | Delta Med SpA | 77 |
| Deltaven | Delta Med SpA | 73 |
| PowerGlide Pro | Bard Access Systems, Inc. | 63 |
| Peripheral Catheter Insertion Kit | Bard Access Systems, Inc. | 62 |
| Able Central Venous Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 62 |
| Curaplex | Bound Tree Medical, LLC | 61 |
| BD Cathena™ Safety IV Catheter | Becton, Dickinson AND Company | 59 |
| Cragg-McNamaraTM | Micro Therapeutics, Inc. | 57 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881666 | 1988-05-06 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2018-08-22 | Class II | Process design | Several lots of Jelco ViaValve” safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process. | 136,600 units | 2021-02-11 |
| Smiths Medical Asd, Inc. | 510(k) number | 2016-11-21 | Class II | Process control | Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves. | 26,750 | 2017-08-01 |
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.