Halyard
2,108 catalogue numbers from DRCC36_0002, listed by Avid Medical, Inc., United States, under Cardiovascular Procedure Kit. 1 manufacturer in China is registered for this product code.
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 | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Premarket notification | Exempt |
| Record published | 2025-05-06 |
| Record revised | 2025-11-20 (version 4) |
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 2, pack of 3, pack of 4, pack of 12, pack of 6, pack of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRCC36_0002 | In distribution | |
| VALD037_0007 | In distribution | |
| NWHR021-01_0009 | In distribution | |
| VAST020-06_0004 | In distribution | |
| RYPH16-03_0005 | In distribution | |
| FGHM100_0013 | In distribution | |
| LLHT24-01_0006 | In distribution | |
| WRNM026-12_0008 | In distribution | |
| VATX015-09_0006 | In distribution | |
| BMHT009-03_0008 | In distribution | |
| WNYH801_0007 | In distribution | |
| VMCC016-10_0002 | In distribution | |
| ESCC82-01_0008 | In distribution | |
| WRNM015-07_0001 | In distribution | |
| COPM11-01_0001 | In distribution | |
| DUOH90-03_0004 | In distribution | |
| JACK425-01_0006 | In distribution | |
| WRNM025-09_0002 | In distribution | |
| ESJH019EVAL_0001 | In distribution | |
| MARS112-01_0001 | In distribution | |
| EUHM006-01_0009 | In distribution | |
| RYPH16-03_0003 | In distribution | |
| FAHC800_0010 | In distribution | |
| EUHB008-02_0005 | In distribution | |
| MSMC122-02_0002 | In distribution | |
| WUCD65-02_0002 | In distribution | |
| JDVA31-02_0006 | In distribution | |
| BMHT017-04_0003 | In distribution | |
| WKMC110-07_0001 | In distribution | |
| HHOH16-02_0007 | In distribution | |
| SGCB55-03_0007 | In distribution | |
| LAKC038-04_0004 | In distribution | |
| YAVA115-08_0003 | In distribution | |
| YAVA115-05_0007 | In distribution | |
| JACK429-08_0001 | In distribution | |
| AMOH32-02_0004 | In distribution | |
| AV010893-03_0014 | In distribution | |
| RYVA88-04_0004 | In distribution | |
| VMCC012-10_0007 | In distribution | |
| SMHS014-08_0012 | In distribution | |
| LLHT24-01_0001 | In distribution | |
| UFCF004-04_0003 | In distribution | |
| LMCB06-01_0004 | In distribution | |
| KDAU203-02_0011 | In distribution | |
| UNAT87-02_0002 | In distribution | |
| RYCB72-04_0025 | In distribution | |
| VAMD0026_0010 | In distribution | |
| WKMC119-01_0002 | In distribution | |
| BMHT107-01_0005 | In distribution | |
| EUHM006-01_0002 | In distribution | |
| WFUM9498-02_0005 | In distribution | |
| EAMC5000-01_0016 | In distribution | |
| ADVR015-19_0008 | In distribution | |
| BUFF9809_0006 | In distribution | |
| SELF120-01_0003 | In distribution | |
| AMMV04AC_0004 | In distribution | |
| WBAM062-09_0003 | In distribution | |
| DUDV85_0001 | In distribution | |
| LAKC017-17_0003 | In distribution | |
| CCCB18-02_0011 | In distribution | |
| EUHM009-03_0001 | In distribution | |
| VMLR072-06_0002 | In distribution | |
| VAML044-03_0008 | In distribution | |
| ESJH008-02_0004 | In distribution | |
| KOOT802-03_0001 | In distribution | |
| SELF105-02_0011 | In distribution | |
| VATX014-08_0007 | In distribution | |
| LANK017-07_0002 | In distribution | |
| VAMM025-04_0008 | In distribution | |
| BPHL802-05_0003 | In distribution | |
| EUHB008-02_0008 | In distribution | |
| YAVA131-03_0002 | In distribution | |
| RYCG37-04_0016 | In distribution | |
| IHOH21-01_0001 | In distribution | |
| MMOR9233-03_0001 | In distribution | |
| KOOT801-01_0002 | In distribution | |
| VMED007-06_0002 | In distribution | |
| BKVA18-02_0001 | In distribution | |
| ADVT027-14_0004 | In distribution | |
| MMTN017-02_0019 | In distribution | |
| MELL44M_0002 | In distribution | |
| MMOK002_0008 | In distribution | |
| LAPM00I_0003 | In distribution | |
| VAST012-08_0004 | In distribution | |
| WRNM015-10_0001 | In distribution | |
| AMPP15-01_0001 | In distribution | |
| NHRM004-03_0002 | In distribution | |
| KNVC001_0008 | In distribution | |
| JACK427-01_0009 | In distribution | |
| UIVA75-01_0002 | In distribution | |
| RYCG37-02_0010 | In distribution | |
| LANC009-34_0008 | In distribution | |
| KDAU203-02_0005 | In distribution | |
| BMHT107-06_0005 | In distribution | |
| MTAH801-02_0002 | In distribution | |
| DUEC64_0001 | In distribution | |
| BKAT14-01_0004 | In distribution | |
| AMOH01AG_0001 | In distribution | |
| DUAV18_0003 | In distribution | |
| SINA249_0007 | In distribution | |
| MHCV04-02_0005 | In distribution | |
| SBHT94B_0001 | In distribution | |
| EAMC5000-01_0014 | In distribution | |
| SHND419-04_0009 | In distribution | |
| MMOK020_0016 | In distribution | |
| YAVA103-04_0006 | In distribution | |
| MMMN001_0023 | In distribution | |
| SELF119-03_0001 | In distribution | |
| LUTH801_0005 | In distribution | |
| VANW018-06_0002 | In distribution | |
| NAPO0078-06_0010 | In distribution | |
| MMTN002-05_0005 | In distribution | |
| VMCC015-10_0006 | In distribution | |
| DRCC36-02_0007 | In distribution | |
| MSBM044-03_0006 | In distribution | |
| JDVA31-03_0002 | In distribution | |
| WRNM021-03_0004 | In distribution | |
| SAMM028-14_0006 | In distribution | |
| ESCC82-01_0004 | In distribution | |
| SLVC001-03_0009 | In distribution | |
| VMCD028-09_0003 | In distribution | |
| MAMC276-04_0001 | In distribution | |
| MSMC121_0009 | In distribution | |
| UFCF009-02_0001 | In distribution | |
| WFUM9497_0007 | In distribution | |
| YAVA103-07_0003 | In distribution | |
| GBVS89-01_0008 | In distribution | |
| VANW024-03_0002 | In distribution | |
| ESJH007-05_0001 | In distribution | |
| VACM009-07_0006 | In distribution | |
| EUHB016-01_0012 | In distribution | |
| SACV80K_0007 | In distribution | |
| VAHT026-16_0002 | In distribution | |
| ALCP49-01_0007 | In distribution | |
| MWHV801-01_0002 | In distribution | |
| RYHT73-03_0012 | In distribution | |
| SHND404-05_0001 | In distribution | |
| KDAU204-03_0001 | In distribution | |
| MTAH801-03_0001 | In distribution | |
| OLMC812-01_0001 | In distribution | |
| SHND419-06_0002 | In distribution | |
| JACK427-08_0002 | In distribution | |
| LLTV10-01_0001 | In distribution | |
| WRNM020-04_0009 | In distribution | |
| SAMM047-13_0005 | In distribution | |
| BMHT012-05_0001 | In distribution | |
| VALD013-05_0005 | In distribution | |
| RYCG37-05_0001 | In distribution | |
| JACK443-02_0004 | In distribution | |
| UFCF004-07_0010 | In distribution | |
| RYVS34-03_0012 | In distribution | |
| SBHT00-01_0004 | In distribution | |
| VANA012-03_0004 | In distribution | |
| JACK443-02_0008 | In distribution | |
| SHAN413-04_0007 | In distribution | |
| KAFB016-03_0003 | In distribution | |
| YAVA103-07_0001 | In distribution | |
| EUHB003-01_0005 | In distribution | |
| RYMN96-04_0004 | In distribution | |
| ALMH800-02_0003 | In distribution | |
| RCAV40-01_0001 | In distribution | |
| SHAN446-01_0009 | In distribution | |
| UTMV78-01_0002 | In distribution | |
| BMHT201-03_0001 | In distribution | |
| MSMC123-01_0002 | In distribution | |
| EUHM009-01_0002 | In distribution | |
| PHCC800_0007 | In distribution | |
| RYVS34-03_0001 | In distribution | |
| JACK438-07_0003 | In distribution | |
| RYCG37-04_0022 | In distribution | |
| RYCB72-04_0017 | In distribution | |
| WKMC120-02_0005 | In distribution | |
| SELF104-04_0001 | In distribution | |
| WRNM021-02_0012 | In distribution | |
| WRNM026-13_0002 | In distribution | |
| WRNM026-12_0003 | In distribution | |
| SLCV01-01_0001 | In distribution | |
| WHEE022-13_0003 | In distribution | |
| MMOK020-02_0002 | In distribution | |
| JACK429-04_0001 | In distribution | |
| SELF104-07_0010 | In distribution | |
| NAFB024-10_0001 | In distribution | |
| PRMH8894_0011 | In distribution | |
| VAML029-07_0007 | In distribution | |
| SBPM82A_0002 | In distribution | |
| VALD013-05_0002 | In distribution | |
| EUHM011-03_0001 | In distribution | |
| VALV201-02_0007 | In distribution | |
| GACH009-01_0012 | In distribution | |
| VAGV052-09_0004 | In distribution | |
| MSBM044-05_0001 | In distribution | |
| UDFP36-01_0003 | In distribution | |
| RYVS34-03_0002 | In distribution | |
| TEMH805_0004 | In distribution | |
| ESJH004-01_0004 | In distribution | |
| RYCD33-05_0008 | In distribution | |
| VAGV043-14_0007 | In distribution | |
| SHAN446-03_0001 | In distribution | |
| NAFB024-11_0003 | In distribution | |
| EUHM009-02_0001 | In distribution | |
| ESJH004-02_0006 | In distribution | |
| VANA012-03_0002 | In distribution | |
| EUHM011-05_0007 | In distribution | |
| BMHT009-05_0009 | In distribution | |
| SFSWECV23-01_0001 | In distribution | |
| SAMM026-15_0001 | In distribution | |
| SHAN434-07_0002 | In distribution | |
| RYCG37-02_0001 | In distribution | |
| BHPM65M_0003 | In distribution | |
| MHCV26-01_0005 | In distribution | |
| AMCF205-03_0002 | In distribution | |
| LAKC038-04_0007 | In distribution | |
| SBHT95A_0001 | In distribution | |
| AMCF210-05_0004 | In distribution | |
| SELF105-04_0017 | In distribution | |
| LMCV54-01_0001 | In distribution | |
| ECAD017-01_0010 | In distribution | |
| DNAZ017-01_0014 | In distribution | |
| ADVS803_0006 | In distribution | |
| NIHB0019-06_0005 | In distribution | |
| VMCC012-13_0016 | In distribution | |
| LAKC020-10_0007 | In distribution | |
| JACK429-09_0001 | In distribution | |
| LAPM00I_0004 | In distribution | |
| VAST015-07_0007 | In distribution | |
| JACK435-03_0003 | In distribution | |
| MSBM044-02_0005 | In distribution | |
| WKMC119-03_0001 | In distribution | |
| SINA221-04_0002 | In distribution | |
| VANA009-02_0004 | In distribution | |
| VAGV015-29_0006 | In distribution | |
| MSBM042-04_0001 | In distribution | |
| DGCC52_0002 | In distribution | |
| RCPM49-01_0001 | In distribution | |
| VANW001-06_0001 | In distribution | |
| NWHR015-01_0009 | In distribution | |
| UFCF009-05_0003 | In distribution | |
| LATH028_0004 | In distribution | |
| WFUM9498_0009 | In distribution | |
| RDLD021-04_0009 | In distribution | |
| SELF120-03_0001 | In distribution | |
| LAKC020-10_0002 | In distribution | |
| CMHM035-03_0002 | In distribution | |
| VANA011-04_0010 | In distribution | |
| VASL008-03_0018 | In distribution | |
| KDAU222-02_0006 | In distribution | |
| YAVA103-05_0002 | In distribution | |
| EABF012-10_0004 | In distribution | |
| ADVS802-02_0001 | In distribution | |
| VALD017-02_0010 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 40,731 |
| Medline Industries, Inc. | Medline Industries, Inc. | 17,468 |
| Avid TruCustom | Avid Medical, Inc. | 2,785 |
| Namic | Medline Industries, Inc. | 2,718 |
| Merit Medical® | Merit Medical Systems, Inc. | 2,399 |
| ACS | American Contract Systems, Inc. | 1,540 |
| Medline | Medline Industries, Inc. | 428 |
| Stradis Healthcare | Stradis Healthcare | 263 |
| Regard™ | ROi CPS LLC | 192 |
| Stradis | Stradis Healthcare | 108 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 72 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 51 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
Recalls Naming This Product
20 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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 | 2025-11-14 | Class II | Nonconforming Material/Component | Potential for incomplete seal on header bag. | 300 units | |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 20 units | |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 20 units | |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-03-31 | Class II | Nonconforming Material/Component | An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use. | 60 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 | 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 | 36 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 | 46 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 | 12 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 | 176 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 | 33 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 | 12 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 | 40 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 | 33 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 | 64 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 | 0 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 | 6 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 | 56 eaches | |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2021-04-09 | Class I | Environmental control | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may resu | 160 kits | 2022-07-18 |
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.