Aligned Medical Solutions
Zulaikha Hospital Angio Pack
3manufacturers in China registered for this device type
120catalogue 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 | Aligned Medical Solutions |
|---|---|
| FDA product code | OEQ |
| Device type | Angiography/Angioplasty Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Premarket notification | Exempt |
| Record published | 2018-11-14 |
| Record revised | 2023-07-28 (version 2) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 6, case of 5, case of 4, case of 8, case of 3, case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RMS1748 | In distribution | |
| AMS15776A | In distribution | |
| AMS6908A | In distribution | |
| RMS1776 | In distribution | |
| AMS13119A | In distribution | |
| AMS10282A | In distribution | |
| AMS1504 | In distribution | |
| AMS19081 | In distribution | |
| AMS18395 | In distribution | |
| AMS9461 | In distribution | |
| AMS15776 | In distribution | |
| AMS1403 | In distribution | |
| AMS15607A | In distribution | |
| AMS7533A | In distribution | |
| AMS7999 | In distribution | |
| AMS10132B | In distribution | |
| AMS14114 | In distribution | |
| AMS10243 | In distribution | |
| AMS18046 | In distribution | |
| AMS13742 | In distribution | |
| AMS8310 | In distribution | |
| 009307-15 | In distribution | |
| AMS6908B | In distribution | |
| AMS17222 | In distribution | |
| AMS1401 | In distribution | |
| AMS9696A | In distribution | |
| AMS6439 | In distribution | |
| AMS17140 | In distribution | |
| RMS1787 | In distribution | |
| AMS6439C | In distribution | |
| AMS7533 | In distribution | |
| AMS6908F | In distribution | |
| AMS8026 | In distribution | |
| AMS18018 | In distribution | |
| AMS10243A | In distribution | |
| AMS15209A | In distribution | |
| AMS15248 | In distribution | |
| AMS8816A | In distribution | |
| AMS3461A | In distribution | |
| AMS13626 | In distribution | |
| AMS15620 | In distribution | |
| AMS11930 | In distribution | |
| AMS14263 | In distribution | |
| AMS17141 | In distribution | |
| AMS16517 | In distribution | |
| AMS6439A | In distribution | |
| AMS14511 | In distribution | |
| AMS14228 | In distribution | |
| AMS16601 | In distribution | |
| PSS3259A | In distribution | |
| AMS9036 | In distribution | |
| AMS1400 | In distribution | |
| AMS16283A | In distribution | |
| AMS9186 | In distribution | |
| DDS-613000121-1 | In distribution | |
| AMS17353 | In distribution | |
| AMS6711A | In distribution | |
| AMS7483A | In distribution | |
| AMS16521 | In distribution | |
| AMS8276B | In distribution | |
| AMS14762 | In distribution | |
| AMS8098 | In distribution | |
| AMS10225C | In distribution | |
| AMS11393 | In distribution | |
| AMS15745 | In distribution | |
| AMS17446 | In distribution | |
| AMS7739 | In distribution | |
| AMS5391 | In distribution | |
| AMS8276 | In distribution | |
| AMS15209 | In distribution | |
| AMS19118 | In distribution | |
| AMS17803 | In distribution | |
| AMS16066 | In distribution | |
| AMS14176 | In distribution | |
| AMS6908E | In distribution | |
| AMS9186D | In distribution | |
| AMS16521A | In distribution | |
| PSS3229A | In distribution | |
| AMS5452 | In distribution | |
| AMS8276A | In distribution | |
| AMS8050A | In distribution | |
| AMS13119 | In distribution | |
| 009307-16 | In distribution | |
| AMS6439B | In distribution | |
| AMS11908 | In distribution | |
| AMS16283 | In distribution | |
| AMS3652C | In distribution | |
| AMS12780 | In distribution | |
| AMS18099 | In distribution | |
| AMS15775 | In distribution | |
| AMS14769 | In distribution | |
| AMS14109 | In distribution | |
| AMS9186A | In distribution | |
| AMS3023 | In distribution | |
| AMS6908G | In distribution | |
| AMS6274A | In distribution | |
| AMS17999 | In distribution | |
| 0013651 | In distribution | |
| AMS7739A | In distribution | |
| 00930712 | In distribution | |
| AMS16611 | In distribution | |
| AMS14263A | In distribution | |
| 0089254 | In distribution | |
| AMS15745A | In distribution | |
| RMS1787A | In distribution | |
| AMS15607 | In distribution | |
| AMS16837 | In distribution | |
| AMS6227A | In distribution | |
| AMS14262 | In distribution | |
| AMS6711B | In distribution | |
| AMS14636 | In distribution | |
| AMS6274B | In distribution | |
| AMS2042 | In distribution | |
| AMS11170 | In distribution | |
| AMS16954 | In distribution | |
| AMS1401A | In distribution | |
| AMS12855 | In distribution | |
| AMS18046A | In distribution | |
| AMS14109A | In distribution | |
| AMS8816 | 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 |
| Regard™ | ROi CPS LLC | 57 |
| Stradis Healthcare | Stradis Healthcare | 33 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 23 |
| Namic | Medline Industries, Inc. | 21 |
| 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
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 |
|---|---|---|---|---|---|---|
| Windstone Medical Packaging, Inc. | UDI-DI | 2026-06-17 | Class II | Material/Component Contamination | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injec | 60 kits |
| Windstone Medical Packaging, Inc. | UDI-DI | 2026-04-02 | Class I | Device Design | Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifol | 150 kits (US only) |
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.