Indeflator
COPILOT Kit includes Bleedback Control Valve 20/30 INDEFLATOR Inflation Device 30 atm 20 cc / Guide Wire Introducer / Torque Device
13manufacturers in China registered for this device type
1catalogue number
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
Showing 12 of 13. All 13 manufacturers in China registered for Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Record
| Listed by | Abbott Vascular, United States |
|---|---|
| FDA product code | DTL |
| Device type | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4290 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-08-05 |
| Record revised | 2020-05-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dry, dark, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1003327 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 171 |
| Namic | Medline Industries, Inc. | 170 |
| Namic | Navilyst Medical, Inc. | 165 |
| Merit® Manifold | Merit Medical Systems, Inc. | 119 |
| Connector | LivaNova USA, Inc. | 70 |
| Medline Industries, Inc. | Medline Industries, Inc. | 62 |
| Demax | Beijing Demax Medical Technology Co., Ltd. | 60 |
| DLP® | Medtronic, Inc. | 51 |
| Marquis® Stopcock | Merit Medical Systems, Inc. | 40 |
| Cook | Cook Incorporated | 38 |
| Unbranded | Advance Medical Designs, Inc. | 30 |
| Contrast Line | Argon Medical Devices, Inc. | 25 |
Showing 12 of 127. All products under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Vascular | UDI-DI | 2024-11-06 | Class II | Component change control | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. | 23,407 |
| Abbott Vascular | UDI-DI | 2022-03-11 | Class II | Component change control | Due to an increase in complaint trend for leaks and intermittent/loose connections. | 131 lots |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-01-07 | Not classified | Process control | Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO ster | 389 units total | 2012-06-26 |
| 2006-12-05 | Not classified | Other | Specific lots of the.096′ and.115′ Rotating Hemostatic Valves (RHV) and the Duostat.096′ Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch | 6090751 – 791 devices, 6090752 – 656 devices, 6091151 – 381 | 2012-07-24 |
| 2006-12-05 | Not classified | Other | Specific lots of the.096′ and.115′ Rotating Hemostatic Valves (RHV) and the Duostat.096′ Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch | 137 devices | 2012-07-24 |
| 2006-12-05 | Not classified | Other | Specific lots of the.096′ and.115′ Rotating Hemostatic Valves (RHV) and the Duostat.096′ Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch | 6090651 – 346 devices, 6090652 – 395 devices, 6090653 – 315 | 2012-07-24 |
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.