Namic
Inflate DEV W/125 Y Adap 20 Fcil&SYR
3manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OEQ |
| Device type | Angiography/Angioplasty Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Premarket notification | Exempt |
| Record published | 2022-02-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
| Packaging | Case of 5 |
| Sizes | Pressure 3040 KiloPascal |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H965914111 | Pressure 3040 KiloPascal | In distribution |
| H965914051 | Pressure 3040 KiloPascal | In distribution |
| H965914151 | Pressure 3040 KiloPascal | In distribution |
| H965914121 | Pressure 3040 KiloPascal | In distribution |
| H965914131 | Pressure 3040 KiloPascal | In distribution |
| H965914141 | Pressure 3040 KiloPascal | In distribution |
| H965914031 | Pressure 3040 KiloPascal | In distribution |
| H965914221 | Pressure 3040 KiloPascal | In distribution |
| H965914041 | Pressure 3040 KiloPascal | In distribution |
| H965914301 | Pressure 3040 KiloPascal | In distribution |
| H965914061 | Pressure 3040 KiloPascal | In distribution |
| H965914211 | Pressure 3040 KiloPascal | In distribution |
| H965914231 | Pressure 3040 KiloPascal | In distribution |
| H965914241 | Pressure 3040 KiloPascal | In distribution |
| H965914091 | Pressure 3040 KiloPascal | In distribution |
| H965914101 | Pressure 3040 KiloPascal | In distribution |
| H965914201 | Pressure 3040 KiloPascal | In distribution |
| H965914021 | Pressure 3040 KiloPascal | In distribution |
| H965914251 | Pressure 3040 KiloPascal | In distribution |
| H965914081 | Pressure 3040 KiloPascal | In distribution |
| H965914071 | Pressure 3040 KiloPascal | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 20,409 |
| Merit Medical® | Merit Medical Systems, Inc. | 3,927 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2,085 |
| ACS | American Contract Systems, Inc. | 428 |
| DeRoyal | Deroyal Industries, Inc. | 283 |
| Aligned Medical Solutions | Aligned Medical Solutions | 120 |
| Regard™ | ROi CPS LLC | 57 |
| Stradis Healthcare | Stradis Healthcare | 33 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 23 |
| basixCOMPAK™ | Merit Medical Systems, Inc. | 8 |
| Stradis | Stradis Healthcare | 7 |
| AccessPLUS™ | Merit Medical Systems, Inc. | 6 |
Showing 12 of 49. All products under Angiography/Angioplasty Kit
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.