Halyard
1,032 catalogue numbers from TPCG001-03_0001, listed by Avid Medical, Inc., United States, under Cardiac Catheterization Kit. 1 manufacturer in China is registered for this product code.
1manufacturer
1,032catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Avid Medical, Inc., United States |
|---|---|
| FDA product code | OES |
| Device type | Cardiac Catheterization Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Premarket notification | Exempt |
| Record published | 2026-03-02 |
| Record revised | 2023-05-12 (version 3) |
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 |
| Storage | Special storage condition: STORE AT ROOM TEMPERATURE |
| Packaging | Pack of 4, pack of 3, pack of 6, pack of 2, pack of 5, pack of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TPCG001-03_0001 | In distribution | |
| VAGV045-16_0015 | In distribution | |
| NAPO0004-12_0010 | In distribution | |
| MVMC001-04_0003 | In distribution | |
| HSCA093-04_0001 | In distribution | |
| RDLD044-06_0003 | In distribution | |
| ESJH001-03_0003 | In distribution | |
| EUHM013-02ANC_0001 | In distribution | |
| AVMD018-04_0002 | In distribution | |
| QEHB001-04_0006 | In distribution | |
| MACL001-05_0005 | In distribution | |
| WBAM020-17_0006 | In distribution | |
| SGCC22_0002 | In distribution | |
| MARS107-01_0006 | In distribution | |
| WRNM066-05_0003 | In distribution | |
| VJCM004_0008 | In distribution | |
| KAFB021-04_0020 | In distribution | |
| SAMM103-05_0002 | In distribution | |
| DRRD48_0009 | In distribution | |
| ESJH011-05_0001 | In distribution | |
| WRNM063-03AUX_0002 | In distribution | |
| NAFB049-06_0009 | In distribution | |
| DGAG83_0002 | In distribution | |
| DGAG83-02_0006 | In distribution | |
| BLCL72L_0005 | In distribution | |
| SGCC22_0005 | In distribution | |
| VAPX021-05_0008 | In distribution | |
| VMCL029-07_0010 | In distribution | |
| SHND401-05_0010 | In distribution | |
| SGRD38_0004 | In distribution | |
| FTCL83-02_0002 | In distribution | |
| WBAM020-17ANC_0002 | In distribution | |
| SMHS010-06_0003 | In distribution | |
| MVMC001-06_0001 | In distribution | |
| BMGT002-05_0003 | In distribution | |
| DAMH303-02_0002 | In distribution | |
| SAMM066-15_0017 | In distribution | |
| SHND400-02_0001 | In distribution | |
| AMCL05N_0003 | In distribution | |
| SHND400-01_0007 | In distribution | |
| VALV214-02_0007 | In distribution | |
| PMRI002-02_0002 | In distribution | |
| VANA017-03_0007 | In distribution | |
| NAPO0004-12AUX_0002 | In distribution | |
| MVMC001-05_0005 | In distribution | |
| VAMH017-02_0003 | In distribution | |
| VAIC014-04_0003 | In distribution | |
| AKRN57-01_0001 | In distribution | |
| SELF129-02_0008 | In distribution | |
| SHSD001_0005 | In distribution | |
| WRNM063-02_0023 | In distribution | |
| SAMM066-18_0001 | In distribution | |
| VHWV016-01_0003 | In distribution | |
| VAIC014-06_0010 | In distribution | |
| BMGT002-03_0002 | In distribution | |
| TPCG001-02_0005 | In distribution | |
| BMHT300AUX_0002 | In distribution | |
| EFAN11-01_0004 | In distribution | |
| RYAN27-03_0017 | In distribution | |
| SHAN403-01_0004 | In distribution | |
| EUHM005-04_0002 | In distribution | |
| PCHM010-06_0005 | In distribution | |
| SWMR019-02_0003 | In distribution | |
| LAKC023-06_0019 | In distribution | |
| VMED005-03_0004 | In distribution | |
| SLBT02-01_0009 | In distribution | |
| MVMC001-06_0005 | In distribution | |
| DGAG83-04_0004 | In distribution | |
| VMCC022-03_0007 | In distribution | |
| WBAM019-08_0024 | In distribution | |
| MMNP009-01_0007 | In distribution | |
| ADVC101-01_0008 | In distribution | |
| EUHM013-06_0008 | In distribution | |
| VMCD029_0010 | In distribution | |
| NAFB049-04_0011 | In distribution | |
| VMCL031-03_0007 | In distribution | |
| SGCC22_0006 | In distribution | |
| SINA237-02_0012 | In distribution | |
| RDLD006-05_0006 | In distribution | |
| SLBT02-01_0006 | In distribution | |
| WBAM066-02_0009 | In distribution | |
| BMHT300-04_0006 | In distribution | |
| WBAM020-13_0010 | In distribution | |
| VAHT001-09_0004 | In distribution | |
| VAMK015-05_0005 | In distribution | |
| ADVG028-36_0004 | In distribution | |
| VHWV015-04_0002 | In distribution | |
| DAMH303-03_0004 | In distribution | |
| ESJH001-02_0002 | In distribution | |
| NWHR023-04_0002 | In distribution | |
| WRNM063-05_0001 | In distribution | |
| CHWE001-02_0005 | In distribution | |
| AVMD006-01_0005 | In distribution | |
| BHAN91M_0010 | In distribution | |
| UWMC003-02_0005 | In distribution | |
| RDLD044-04_0004 | In distribution | |
| PHLS029_0004 | In distribution | |
| RDLD044-02_0008 | In distribution | |
| VMLR047-09_0002 | In distribution | |
| GRAN017-02_0002 | In distribution | |
| SHAN430-06_0003 | In distribution | |
| LLAP75-01_0002 | In distribution | |
| WRNM063-04_0003 | In distribution | |
| SINA238-04_0008 | In distribution | |
| VAMK023-02_0008 | In distribution | |
| EAMC2000-07_0005 | In distribution | |
| VMCC021-06_0004 | In distribution | |
| VMLR035-05AUX_0003 | In distribution | |
| SAMM037-16_0004 | In distribution | |
| OBVA013-05_0004 | In distribution | |
| ESCA33-02_0001 | In distribution | |
| VARV042-03_0008 | In distribution | |
| UWMC001-03_0005 | In distribution | |
| MMSY005-01_0001 | In distribution | |
| VAMK015-04_0005 | In distribution | |
| VASL018-01_0009 | In distribution | |
| BKAN12-02_0001 | In distribution | |
| VACT004-04_0007 | In distribution | |
| EFAN11-01_0001 | In distribution | |
| MAMC218-22_0008 | In distribution | |
| NAFB049-05_0001 | In distribution | |
| MAMC230-15_0005 | In distribution | |
| EAMC7000-07_0005 | In distribution | |
| VANW017-04_0007 | In distribution | |
| NAPO0001-14_0013 | In distribution | |
| LANC095-08_0004 | In distribution | |
| VARV042-02_0005 | In distribution | |
| VSEL003-04_0006 | In distribution | |
| MSBM004-03_0006 | In distribution | |
| SHAN403-03_0006 | In distribution | |
| MMSY005_0010 | In distribution | |
| UMIA100-01_0011 | In distribution | |
| OBVA010-03_0007 | In distribution | |
| VALV213-01_0013 | In distribution | |
| MIHS013-06_0005 | In distribution | |
| NAFB049-04_0013 | In distribution | |
| NAFB049-05_0004 | In distribution | |
| HSAM001-15_0009 | In distribution | |
| EURO049_0002 | In distribution | |
| ESJH001-03_0007 | In distribution | |
| DAMH301-03_0001 | In distribution | |
| UWMC003-03_0008 | In distribution | |
| WBAM020-15_0004 | In distribution | |
| SWMR012-03_0007 | In distribution | |
| RYAN27-04_0003 | In distribution | |
| PMHS020-03_0004 | In distribution | |
| SAMM066-15_0012 | In distribution | |
| CYMH109-01_0005 | In distribution | |
| ESCA33-01_0001 | In distribution | |
| EUHM013-04_0004 | In distribution | |
| SJGH101-03_0001 | In distribution | |
| BMHT300_0012 | In distribution | |
| DUAG57_0008 | In distribution | |
| VANW017-04_0011 | In distribution | |
| DGAG83-03_0008 | In distribution | |
| VAML023-06_0004 | In distribution | |
| UNCL72-02_0004 | In distribution | |
| MSBM003-04_0005 | In distribution | |
| RDLD046-01_0003 | In distribution | |
| AVMD038_0007 | In distribution | |
| EFAN11-01_0008 | In distribution | |
| GSLP001-05_0001 | In distribution | |
| VASL011-07_0003 | In distribution | |
| AVMD016-02_0002 | In distribution | |
| HCIL001-02_0009 | In distribution | |
| DRRD48_0004 | In distribution | |
| MSBM004-05_0002 | In distribution | |
| DGAR14_0006 | In distribution | |
| SFSUIPL77-01_0001 | In distribution | |
| LANC002-18_0009 | In distribution | |
| AMCF200-01_0003 | In distribution | |
| EUHM005-05_0009 | In distribution | |
| ESCA33-01_0007 | In distribution | |
| RDLD006-08_0001 | In distribution | |
| LANK027-01_0034 | In distribution | |
| VAML024-03_0004 | In distribution | |
| RMHP001-01_0025 | In distribution | |
| BMHT104_0004 | In distribution | |
| VHWV015-04_0001 | In distribution | |
| BLCL72L_0009 | In distribution | |
| VANW016-05_0011 | In distribution | |
| SINA236-02_0006 | In distribution | |
| SAMM066-15_0015 | In distribution | |
| HSAM001-16_0004 | In distribution | |
| ACAG21-01_0004 | In distribution | |
| EUHM005-05_0003 | In distribution | |
| ESJH001-04_0004 | In distribution | |
| SINA238-05_0002 | In distribution | |
| VALD029-06_0002 | In distribution | |
| MMCC005-01_0004 | In distribution | |
| DUAD22-01_0006 | In distribution | |
| NAFB029-10_0001 | In distribution | |
| BMHT600_0001 | In distribution | |
| MVMC001-06_0002 | In distribution | |
| BHAN91M_0006 | In distribution | |
| YAVA100-07_0003 | In distribution | |
| LANC059-06_0015 | In distribution | |
| ESJH011-01_0006 | In distribution | |
| YAVA100-06_0002 | In distribution | |
| MMTN015_0017 | In distribution | |
| VMCD029_0008 | In distribution | |
| EUHM013-04_0008 | In distribution | |
| WKMC115_0006 | In distribution | |
| DAMH303-04_0001 | In distribution | |
| HSCA093-03_0001 | In distribution | |
| WECC13-03_0003 | In distribution | |
| SHAN403-02_0002 | In distribution | |
| WMHH202-02_0004 | In distribution | |
| VMCL029-06_0002 | In distribution | |
| VASL007-04_0013 | In distribution | |
| AVMD006-01_0006 | In distribution | |
| DRRD48_0003 | In distribution | |
| MAMC217-20_0002 | In distribution | |
| SAMM037-17_0002 | In distribution | |
| NAMC477_0006 | In distribution | |
| WRNM064-04_0020 | In distribution | |
| VAHT043_0008 | In distribution | |
| NAFB029-09_0002 | In distribution | |
| WBAM020-12_0005 | In distribution | |
| RMHP013-04_0002 | In distribution | |
| SJGH113-01_0004 | In distribution | |
| BMHT300_0010 | In distribution | |
| RDLD044-07_0002 | In distribution | |
| SGAR20-01 | In distribution | |
| EUHM005-03_0001 | In distribution | |
| VADA009-04_0008 | In distribution | |
| SFSIHCC03-01_0003 | In distribution | |
| UWMC001-03_0002 | In distribution | |
| NAPO0069-02_0011 | In distribution | |
| SAMM048-15_0011 | In distribution | |
| VHWV015-03_0003 | In distribution | |
| BKAN12-01_0008 | In distribution | |
| VMCL025-11_0002 | In distribution | |
| MECL20X_0002 | In distribution | |
| AMCF200-04_0001 | In distribution | |
| BMHT104-01_0002 | In distribution | |
| DUAG57_0001 | In distribution | |
| ACAG21-01_0001 | In distribution | |
| YAVA100-07_0001 | In distribution | |
| RDVA013-04_0004 | In distribution | |
| VALV214-02_0006 | In distribution | |
| RDLD046-01_0005 | In distribution | |
| WBAM019-12_0002 | In distribution | |
| MAMC230-12_0007 | In distribution | |
| MMTN023_0010 | In distribution | |
| EFAN11-01_0007 | In distribution | |
| SAMM103-05_0009 | In distribution | |
| AV010930-13_0010 | In distribution | |
| PSSC004-01_0005 | In distribution | |
| VAST043_0006 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 7,486 |
| Cardinal Health | Cardinal Health 200, LLC | 2,706 |
| Avid TruCustom | Avid Medical, Inc. | 1,173 |
| Centurion | Centurion Medical Products Corporation | 1,077 |
| Medline Industries, Inc. | Centurion Medical Products Corporation | 775 |
| Medline | Medline Industries, Inc. | 465 |
| ACS | American Contract Systems, Inc. | 344 |
| Regard™ | ROi CPS LLC | 138 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 79 |
| Aligned Medical Solutions | Aligned Medical Solutions | 72 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 24 |
| Namic | Medline Industries, Inc. | 14 |
Showing 12 of 18. All products under Cardiac Catheterization Kit
Recalls Naming This Product
19 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-08-10 | Not classified | Nonconforming Material/Component | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. | 340 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-05-19 | Class II | Process change control | Defects in the silicone seal, which may result in “doming” of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. | 112 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-04-30 | Class I | Under Investigation by firm | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to b | 5168 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-04-30 | Class I | Under Investigation by firm | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to b | 5168 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 80 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 24 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 30 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 411 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 300 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 24 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 216 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 288 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 42 eahes |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 44 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 138 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 114 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 232 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 284 eaches |
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.