ACS
Interventional Radiology Pack - 205953
3manufacturers in China registered for this device type
428catalogue numbers in this listing
6recalls on this code
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 | American Contract Systems, Inc. |
|---|---|
| FDA product code | OEQ |
| Device type | Angiography/Angioplasty Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Premarket notification | Exempt |
| Record published | 2021-03-03 |
| Record revised | 2022-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLCL55E | In distribution | |
| EMMY36I | In distribution | |
| BHSP82N | In distribution | |
| BPAT45A | In distribution | |
| ANSG81T | In distribution | |
| NCST38H | In distribution | |
| BPCL47C | In distribution | |
| BPAT45B | In distribution | |
| RWAN63H | In distribution | |
| LASP09AA | In distribution | |
| ANSG81W | In distribution | |
| ANLO82S | In distribution | |
| NCAG62G | In distribution | |
| TOEP53P | In distribution | |
| AGAD45M | In distribution | |
| SJMY36F | In distribution | |
| MHEP38AK | In distribution | |
| BLEP74I | In distribution | |
| SSAR20E | In distribution | |
| LLPE21J | In distribution | |
| SAAN71W | In distribution | |
| ANSG81V | In distribution | |
| LLAP75G | In distribution | |
| KPAN50M | In distribution | |
| EMIN21F | In distribution | |
| RCAR42A | In distribution | |
| UDIN23AC | In distribution | |
| WEAG48D | In distribution | |
| ANIR77AE | In distribution | |
| LBCD39C | In distribution | |
| YOAN44B | In distribution | |
| HSAN63J | In distribution | |
| MHIR48F | In distribution | |
| HSAN63N | In distribution | |
| DMAN36E | In distribution | |
| BPRD66D | In distribution | |
| ANLO82P | In distribution | |
| BHAN91L | In distribution | |
| MTAN13C | In distribution | |
| UMNS28D | In distribution | |
| TOAN54N | In distribution | |
| LLAP75E | In distribution | |
| HSAN63L | In distribution | |
| ANCA80AJ | In distribution | |
| JEIR37K | In distribution | |
| FIEV51E | In distribution | |
| UDCO10F | In distribution | |
| SJAR31G | In distribution | |
| MHAN60E | In distribution | |
| LLAP75I | In distribution | |
| LSRANGIRM21H | In distribution | |
| UDCO10E | In distribution | |
| FBAN48M | In distribution | |
| SLSP77D | In distribution | |
| BHAN91M | In distribution | |
| FBAN48L | In distribution | |
| FBAN48H | In distribution | |
| UIPA61O | In distribution | |
| SLPC34M | In distribution | |
| LMAG01Q | In distribution | |
| RWIR61E | In distribution | |
| WERD19B | In distribution | |
| LBCD39B | In distribution | |
| UDIN23AA | In distribution | |
| BMAN16E | In distribution | |
| ANSG81R | In distribution | |
| YOAN44A | In distribution | |
| BHAN74D | In distribution | |
| ESMK00A | In distribution | |
| ANCA80AH | In distribution | |
| BHAN91J | In distribution | |
| ANEP76AE | In distribution | |
| SLPC35A | In distribution | |
| AGAD45J | In distribution | |
| FLAR01H | In distribution | |
| LBCD39A | In distribution | |
| SLEP03F | In distribution | |
| MEEP10E | In distribution | |
| SLSP12F | In distribution | |
| ANCA80AM | In distribution | |
| TMAN84G | In distribution | |
| LLLR48C | In distribution | |
| WEAG48G | In distribution | |
| NCAG62H | In distribution | |
| MHHY51K | In distribution | |
| ALAN14B | In distribution | |
| BPAD76A | In distribution | |
| RIAN04C | In distribution | |
| AMDP06N | In distribution | |
| ESCA33A | In distribution | |
| JCEP52C | In distribution | |
| FBDI42I | In distribution | |
| HSAN63I | In distribution | |
| IHEP07O | In distribution | |
| CXDP36M | In distribution | |
| SLPC34N | In distribution | |
| FBAN48G | In distribution | |
| HGSM40E | In distribution | |
| LMEP23K | In distribution | |
| FIEV51B | In distribution | |
| SAAN71U | In distribution | |
| BDAG39B | In distribution | |
| MTAN13A | In distribution | |
| RCAR42C | In distribution | |
| NLAN32C | In distribution | |
| SLSP77G | In distribution | |
| HGSM40I | In distribution | |
| AGEP48G | In distribution | |
| FHAG11Z | In distribution | |
| RIAN04D | In distribution | |
| BMAN16F | In distribution | |
| MHEP38AL | In distribution | |
| BHAN91K | In distribution | |
| LLPE21I | In distribution | |
| WHAI40D | In distribution | |
| CXAG60M | In distribution | |
| AGDI40I | In distribution | |
| BLMY64I | In distribution | |
| CXAN39N | In distribution | |
| UIPA61P | In distribution | |
| MHPG90A | In distribution | |
| BPCL47E | In distribution | |
| LASP09Z | In distribution | |
| UDPV21B | In distribution | |
| LMRA33S | In distribution | |
| CEAT19Q | In distribution | |
| LLPR15H | In distribution | |
| FHRA27M | In distribution | |
| ANCA80AK | In distribution | |
| BLMY64H | In distribution | |
| UDPV21D | In distribution | |
| SLPC34H | In distribution | |
| SNRA80H | In distribution | |
| FBAN48J | In distribution | |
| MHCA98AI | In distribution | |
| ANIR77AC | In distribution | |
| BDAG39C | In distribution | |
| BLPR16E | In distribution | |
| AGAD45I | In distribution | |
| EMMY36J | In distribution | |
| MMCC14B | In distribution | |
| NLAN32D | In distribution | |
| BHMY98G | In distribution | |
| LMEP23J | In distribution | |
| TPIR15C | In distribution | |
| LSRARTDATANGB | In distribution | |
| AGAD45O | In distribution | |
| LMAG01N | In distribution | |
| WPAN34E | In distribution | |
| UDVK77X | In distribution | |
| JEIR37J | In distribution | |
| ANSG81U | In distribution | |
| UDIN23AB | In distribution | |
| MHHY51G | In distribution | |
| WERD19C | In distribution | |
| CXAG60N | In distribution | |
| NCST38F | In distribution | |
| LMRA33P | In distribution | |
| ACAG21A | In distribution | |
| AGBI64I | In distribution | |
| IHAN02T | In distribution | |
| MPRM25E | In distribution | |
| MEAN19R | In distribution | |
| LLEC88D | In distribution | |
| SLPC34I | In distribution | |
| IHAN02S | In distribution | |
| SLPC34J | In distribution | |
| BMAN16G | In distribution | |
| LLPE21F | In distribution | |
| HGSM40G | In distribution | |
| LMAG01O | In distribution | |
| YORD73D | In distribution | |
| BLPR16F | In distribution | |
| UDVK77Y | In distribution | |
| TMAN84H | In distribution | |
| UIPA61U | In distribution | |
| BHSP82L | In distribution | |
| FHAG11AA | In distribution | |
| SJAN17J | In distribution | |
| CEEP05H | In distribution | |
| SLPC34L | In distribution | |
| MTAN13B | In distribution | |
| FBDI42G | In distribution | |
| HGSM40F | In distribution | |
| RCAN45B | In distribution | |
| FBDI42H | In distribution | |
| DMPC72I | In distribution | |
| UIPA61T | In distribution | |
| FHRA27O | In distribution | |
| EJAG58A | In distribution | |
| UDPV21G | In distribution | |
| HSRS90C | In distribution | |
| GMAN15G | In distribution | |
| LLAN17F | In distribution | |
| LMEP23L | In distribution | |
| UDPV21E | In distribution | |
| MMCC14A | In distribution | |
| HSRS90B | In distribution | |
| WEAG48E | In distribution | |
| LMNA91F | In distribution | |
| ANCA80AF | In distribution | |
| LBAG43B | In distribution | |
| BLEP74H | In distribution | |
| LSRARTDATANGC | In distribution | |
| GSAN26E | In distribution | |
| MHHY51I | In distribution | |
| UHIR20AD | In distribution | |
| LSRSMRESALB | In distribution | |
| SNRA80F | In distribution | |
| UHIR20AE | In distribution | |
| KPAN50L | In distribution | |
| SGIR38A | In distribution | |
| HSRS90D | In distribution | |
| ANCA80AI | In distribution | |
| UDIR58AH | In distribution | |
| GMAN15F | In distribution | |
| TMAN84E | In distribution | |
| FTAN81G | In distribution | |
| SLPC35B | In distribution | |
| HGHY84K | In distribution | |
| GSAN26F | In distribution | |
| BLSP06J | In distribution | |
| LMRA33R | In distribution | |
| BLMY64J | In distribution | |
| UDCO10G | In distribution | |
| MEAN19Q | In distribution | |
| BPPA31A | In distribution | |
| UDAN77AD | In distribution | |
| FTAN81I | In distribution | |
| GSAN26G | In distribution | |
| LLEC88E | In distribution | |
| RCAR42B | In distribution | |
| JNCL00A | In distribution | |
| FBEA44G | In distribution | |
| IHAN02U | In distribution | |
| HGSM40H | In distribution | |
| MEAN19S | In distribution | |
| UHIR20Z | In distribution | |
| LKEP42H | In distribution | |
| MPRI30E | In distribution | |
| MHIR99AG | In distribution | |
| HBFA20C | In distribution | |
| BMAN16H | In distribution | |
| FBEA44H | In distribution | |
| RWIR61D | In distribution | |
| CXRD75U | In distribution | |
| SAAN71X | In distribution | |
| UDPV21A | In distribution | |
| LMAN19W | In distribution | |
| MTAM20A | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| 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
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 956 kits |
| American Contract Systems, Inc. | UDI-DI | 2024-08-07 | Class II | Under Investigation by firm | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. | 1 unit |
| American Contract Systems, Inc. | UDI-DI | 2024-05-06 | Class II | Under Investigation by firm | Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility | 112 |
| American Contract Systems, Inc. | UDI-DI | 2022-03-22 | Class II | Process control | Product was sterilized with a higher than specification EO concentration. | 24 packs |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2025-09-04 | Class II | Nonconforming Material/Component | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycle | 32,433 total | |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 57 units | |
| 2020-04-13 | Class II | Process control | The surgical gowns were manufactured in a facility that is not registered by the FDA. | 2868 total kits | 2020-11-25 |
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.