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.

Registry build 21.09.26
1manufacturer
2,108catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OEZ
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Record

Regulatory record for Halyard
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

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 numbers for Halyard
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.

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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.

Recalls naming the identifiers of Halyard
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer