Cardinal Health
Pulmonary Artery Catheterization Drape BNS
39manufacturers in China registered for this device type
111catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (14), Zhejiang (6), Guangdong (6). 21 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 39. All 39 manufacturers in China registered for Drape, Surgical, Antimicrobial
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-15 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 25, case of 12, case of 5, case of 20, case of 4 |
| Distribution end date | 2021-05-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SBA40CDECA | In distribution | ||
| SID23PDUCB | In distribution | ||
| SID23LAMUB | In distribution | ||
| SBA22LPMRA | In distribution | ||
| SID49SPMBA | In distribution | ||
| SID13PFDHA | In distribution | ||
| SOP41EDOKA | In distribution | ||
| SMA23LDCMA | In distribution | ||
| SIDHDCDCHA | In distribution | ||
| SCV31CVUCA | In distribution | ||
| SID13VABHA | In distribution | ||
| SID11DRMMB | In distribution | ||
| SBA56GSIHA | In distribution | ||
| SBA26DPHRA | In distribution | ||
| 44203MNS | 10 | In distribution | |
| SID13DRDHD | In distribution | ||
| SID63RAOLA | In distribution | ||
| SBA19NACWB | In distribution | ||
| SID23NDUCB | In distribution | ||
| 14-0088 | In distribution | ||
| SBA16LDSMA | In distribution | ||
| SID23TDRMC | In distribution | ||
| SBA4AMTJHA | In distribution | ||
| SID31NEUIA | In distribution | ||
| SID23LANCC | In distribution | ||
| SBA40CRCCA | In distribution | ||
| SBA21CVEGA | In distribution | ||
| SID43DPMFA | In distribution | ||
| SEY37DPGSA | In distribution | ||
| SBA13AHDHB | In distribution | ||
| SID56CPIHB | In distribution | ||
| SID12BLUVA | In distribution | ||
| SID33SPRHA | In distribution | ||
| SID95PDDUC | In distribution | ||
| SID11DRMMA | In distribution | ||
| SMA32LDSPA | In distribution | ||
| SOPW1DRGGA | In distribution | ||
| SBA4JLCMUA | In distribution | ||
| SID23OTCMB | In distribution | ||
| SBA23LINCB | In distribution | ||
| SBA23DPCMB | In distribution | ||
| SID57DLSHB | In distribution | ||
| SID12CVUVB | In distribution | ||
| SLC11LDCPA | In distribution | ||
| SID25TPHSC | In distribution | ||
| SID33VPRHB | In distribution | ||
| 44040MNS | 16 | In distribution | |
| SID11LVMKA | In distribution | ||
| SMA23LDCMB | In distribution | ||
| SBA19NACWC | In distribution | ||
| SID44CVTCC | In distribution | ||
| SBA73PPKWA | In distribution | ||
| SBAHDMBUMA | In distribution | ||
| SBAHDCDSUF | In distribution | ||
| 17-5710A | In distribution | ||
| SAN23PAPCA | In distribution | ||
| SBAHDTDMMA | In distribution | ||
| 45067MNS | 10 | In distribution | |
| SMA56CDIHB | In distribution | ||
| SBA13CAMRA | In distribution | ||
| SBA43PDOFB | In distribution | ||
| 045297MNSA | In distribution | ||
| SBA21LDSJC | In distribution | ||
| SOP60TPNBA | In distribution | ||
| SBA12RAHMA | In distribution | ||
| SMA11CDCPA | In distribution | ||
| SID38PDSFA | In distribution | ||
| SMA4ACCJHA | In distribution | ||
| SID23TRCMB | In distribution | ||
| SBA13SDCBA | In distribution | ||
| SNE41CIMFA | In distribution | ||
| SBAHDCDSUG | In distribution | ||
| SMA56CDIHA | In distribution | ||
| SAN35CDCHB | In distribution | ||
| SMA23LDNVA | In distribution | ||
| SID57PDOHA | In distribution | ||
| SID13UDCAA | In distribution | ||
| SBA13OFDHB | In distribution | ||
| SBAW1UDHFA | In distribution | ||
| SID73OTCMB | In distribution | ||
| SIDDHDPNHA | In distribution | ||
| SID21DKPMA | In distribution | ||
| SLC73PLCHA | In distribution | ||
| SBA55DPKFA | In distribution | ||
| SBA41BDMOA | In distribution | ||
| 44028MNS | 10 | In distribution | |
| SID4FUBRHA | In distribution | ||
| SCV08CVOHA | In distribution | ||
| SMA5CCSULA | In distribution | ||
| SBA19PACWC | In distribution | ||
| 44185TNS | 6 | Withdrawn | |
| 44266NS | 10 | Withdrawn | |
| 44147MNS | 7 | Withdrawn | |
| 43543TNS | 12 | Withdrawn | |
| 45005TNS | 25 | Withdrawn | |
| 45211MNS | 20 | Withdrawn | |
| 43537TNS | 10 | Withdrawn | |
| 44243TNS | 8 | Withdrawn | |
| 43145TNS | 30 | Withdrawn | |
| 43391TNS | 8 | Withdrawn | |
| 44223TNS | 6 | Withdrawn | |
| 43509TNS | 12 | Withdrawn | |
| 44187TNS | 8 | Withdrawn | |
| 43418TNS | 10 | Withdrawn | |
| 44141TNS | 10 | Withdrawn | |
| 44028TNS | 10 | Withdrawn | |
| 43482TNS | 6 | Withdrawn | |
| 44038NS | 70 | Withdrawn | |
| 45155TNS | 6 | Withdrawn | |
| 43538TNS | 10 | Withdrawn | |
| 44225TNS | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 994 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 819 |
| Halyard | O&M Halyard, Inc. | 800 |
| Medline | Medline Industries, Inc. | 517 |
| Convertors | Cardinal Health 200, LLC | 392 |
| Medline Industries, Inc. | Medline Industries, Inc. | 274 |
| TIDIShield | Tidi Products, LLC | 187 |
| DeRoyal | Deroyal Industries, Inc. | 118 |
| Angiosystems Drape | Angiosystems, Inc. | 109 |
| ComPel Surgical Drape | Standard Textile Co., Inc. | 101 |
| Drape, Surgical, Antimicrobial | Welmed, Inc. | 95 |
| Novo Health Services, LLC | Novo Health Services, LLC | 90 |
Showing 12 of 329. All products under Drape, Surgical, Antimicrobial
Recalls
2 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 |
|---|---|---|---|---|---|
| 2017-06-27 | Class II | Mixed-up of materials/components | Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside. | 528 each | 2019-03-29 |
| 2017-06-27 | Class II | Mixed-up of materials/components | Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside. | 1591 each | 2019-03-29 |
| 2006-09-27 | Not classified | Other | The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use. | 1982 units | 2008-05-09 |
| 2006-09-27 | Not classified | Other | The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use. | 1086 units | 2008-05-09 |
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.