CIV-Clear™ Transducer Cover
CIV-Clear Transducer Cover forms a microbial barrier between a patient and ultrasound imaging equipment. It is offered in different sizes for sterile or nonsterile procedural fields. The…
CIV-Clear Transducer Cover forms a microbial barrier between a patient and ultrasound imaging equipment. It is offered in different sizes for sterile or nonsterile procedural fields. The cover material is a blend of ethyl methyl acrylate and polyethylene rather than a coated coupling pad.
The covers are intended for adults during abdominal, small-parts, regional anesthesia, vascular-access, surgical, transesophageal, transrectal and transvaginal ultrasound applications. Depending on the application, these include diagnostic imaging, minimally invasive puncture, catheter placement or cardiac monitoring.
Listed Item
Sterile (10.2x122cm) telescopically-folded cover (no gel)
Coupling and Sterile Supply
Ultrasound gel is placed inside the cover or on the transducer face to provide acoustic coupling. Sterile configurations use ethylene oxide sterilization, and the stated shelf life is three years. The material is described as a viral barrier for microbes 27 nanometers and larger.
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (10), Shanghai (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Showing 12 of 44. All 44 manufacturers in China registered for Transducer, Ultrasonic, Diagnostic
Record
| Listed by | Civco Medical Instruments Co., Inc., United States |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K211270 |
| Record published | 2021-11-20 |
| Record revised | 2022-10-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Away from Sunlight |
| Packaging | Pack of 24, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 610-2362 | In distribution | ||
| 610-2365 | In distribution | ||
| 610-2363 | In distribution | ||
| 610-2366 | In distribution | ||
| 610-2367 | In distribution | ||
| 610-2364 | In distribution | ||
| 610-2361 | In distribution | ||
| 610-2389 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 302 |
| Biopsy Starter Kit | Civco Medical Instruments Co., Inc. | 172 |
| Sheathes | Sheathing Technologies, Inc. | 170 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 156 |
| Sheathes3D | Sheathing Technologies, Inc. | 78 |
| Ultrasound Probe Cover Biopsy Needle Guide | Advance Medical Designs, Inc. | 78 |
| ultrasonic transducer | Edan Instruments, Inc. | 70 |
| Unbranded | Advance Medical Designs, Inc. | 68 |
| Reusable Biopsy Bracket | Protek Medical Products, Inc. | 60 |
| Ultrasound Probe Cover Biopsy Needle Guide Kit | Advance Medical Designs, Inc. | 58 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 56 |
| Transducer Cover | Civco Medical Instruments Co., Inc. | 54 |
Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231783 | 2023-11-14 |
| K222052 | 2022-11-22 |
| K211270 | 2021-09-13 |
| K163313 | 2017-06-09 |
| K160806 | 2016-08-05 |
| K131161 | 2013-09-17 |
| K131528 | 2013-06-11 |
| K093713 | 2010-01-19 |
| K013721 | 2001-12-28 |
| K992152 | 1999-08-17 |
| K991236 | 1999-06-02 |
| K970513 | 1997-06-20 |
| K970514 | 1997-06-20 |
| K970515 | 1997-06-20 |
| K843573 | 1984-12-13 |
Recalls
25 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 |
|---|---|---|---|---|---|
| 2025-05-01 | Class II | Process design | During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place. | 506 boxes | |
| 2018-11-02 | Class II | Other | 613 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 49 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 66 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 20 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 234 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 115 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. | 948 boxes | 2020-11-20 |
| 2018-11-02 | Class II | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. | 738 boxes | 2020-11-20 |
| 2018-11-02 | Class II | Other | 73 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 257 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 468 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 3 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 297 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. | 1,375 boxes | 2020-11-20 |
| 2018-11-02 | Class II | Other | 135 boxes | 2020-11-20 | |
| 2018-07-30 | Class II | Process control | The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide. | 3 units | 2020-09-16 |
| 2018-07-30 | Class II | Process control | The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide. | 107 units | 2020-09-16 |
| 2018-02-23 | Class II | Device Design | A cover failed leak testing during validation testing of new needle guides from a replacement tool. | 177 boxes | 2020-10-06 |
| 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 54 boxes | 2017-02-28 |
| 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 717 boxes | 2017-02-28 |
| 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 206 boxes | 2017-02-28 |
| 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 1139 boxes | 2017-02-28 |
| 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 508 boxes | 2017-02-28 |
| 2015-02-26 | Class II | Process design | Leaks were detected in the recalled lot which may compromise the sterility of the product. | 120 pouches | 2017-02-28 |
| 2011-01-21 | Not classified | Labeling design | Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information. | 31/24-cover boxes | 2013-07-09 |
| 2010-07-20 | Not classified | Nonconforming Material/Component | Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover. | 22 boxes | 2012-04-13 |
| 2008-01-16 | Not classified | Packaging | Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054). | Lot M102250 – 5 boxes; Lot M105440 – 2 boxes | 2008-04-03 |
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.