Convertors
Cardiovascular Surgical Drape Split 84inx147in Armboard Width 115in With Velcro Troughs and Clear Anesthesia Screen BNS
107manufacturers in China registered for this device type
1,573catalogue numbers in this listing
10recalls on this code
Who Else Makes It
Concentrated in Jiangsu (28), Guangdong (17), Hubei (14). 43 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Henan Yadu Industrial Co., Ltd. | Changyuan | Henan | Contract manufacturer | 35 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Yadu Medical (Henan) Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 107. All 107 manufacturers in China registered for Drape, Surgical, Exempt
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | PUI |
| Device type | Drape, Surgical, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-06-28 |
| Record revised | 2025-03-31 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 20, case of 12, case of 8, case of 30, case of 7 |
| Sizes | Width 60 to 124 in; length 166 in |
| Distribution end date | 2028-08-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TB9349NB | 840 | In distribution | |
| 41005NS | 4 | In distribution | |
| 29455 | In distribution | ||
| 44191TNS | 10 | In distribution | |
| D2158 | In distribution | ||
| D2310NSC | 30 | In distribution | |
| 29066N | 5 | In distribution | |
| 29422NB | 448 | In distribution | |
| 29430 | In distribution | ||
| 29520N | 16 | In distribution | |
| 9361NB | 572 | In distribution | |
| 45233TNS | 8 | In distribution | |
| 59439NA | 108 | In distribution | |
| 29365N | 20 | In distribution | |
| 43312MNS | 10 | In distribution | |
| 29570N | 12 | In distribution | |
| 43221TNS | 100 | In distribution | |
| 9447N | 9 | In distribution | |
| 44009TNS | 7 | In distribution | |
| 9461N | 96 | In distribution | |
| 42096MNS | 14 | In distribution | |
| 47165TNS | 6 | In distribution | |
| C2411 | In distribution | ||
| K9458N | 10 | In distribution | |
| 48066TNS | 10 | In distribution | |
| 29575 | In distribution | ||
| 8430NA | 1,280 | In distribution | |
| 8187N | 30 | In distribution | |
| ME28985 | 100 | In distribution | |
| 45196TNS | 12 | In distribution | |
| 45078MNS | 6 | In distribution | |
| 29421 | In distribution | ||
| 29414NC | 364 | In distribution | |
| 43572TNS | 6 | In distribution | |
| 48137TNS | 12 | In distribution | |
| 45323MNS | 8 | In distribution | |
| D1067NS | 50 | In distribution | |
| 46149MNS | 5 | In distribution | |
| 44300TNS | 6 | In distribution | |
| M9471 | In distribution | ||
| 8475N | 80 | In distribution | |
| 48125MNS | 6 | In distribution | |
| 45229TNS | 6 | In distribution | |
| 9158NC | 156 | In distribution | |
| 45238TNS | 6 | In distribution | |
| 49603TNS | 6 | In distribution | |
| 9777N | 200 | In distribution | |
| 3524 | In distribution | ||
| 43431TNS | 20 | In distribution | |
| D2298NSC | 40 | In distribution | |
| 48131TNS | 5 | In distribution | |
| C29458 | In distribution | ||
| 29417 | In distribution | ||
| 49306NS | 7 | In distribution | |
| 29556 | In distribution | ||
| 29522NB | 336 | In distribution | |
| 8183N | 1,280 | In distribution | |
| 48156TNS | 6 | In distribution | |
| D1018NS | 200 | In distribution | |
| 44273TNS | 6 | In distribution | |
| 43744MNS | 10 | In distribution | |
| 29510NB | 364 | In distribution | |
| 29575N | 10 | In distribution | |
| 8474N | 110 | In distribution | |
| 47180TNS | 8 | In distribution | |
| 59427N | 182 | In distribution | |
| D1092 | In distribution | ||
| MED27084NS | 360 | In distribution | |
| D2264NS | 50 | In distribution | |
| 29414 | In distribution | ||
| 48254NS | 6 | In distribution | |
| 9430 | In distribution | ||
| 43671MNS | 40 | In distribution | |
| 29431N | 15 | In distribution | |
| D2264 | In distribution | ||
| 48230NS | 6 | In distribution | |
| 45279MNS | 6 | In distribution | |
| 8189N | 1,000 | In distribution | |
| D1019NS | 100 | In distribution | |
| C2242 | In distribution | ||
| 49436TNS | 8 | In distribution | |
| 8484NA | 2,000 | In distribution | |
| 7554 | 2 | In distribution | |
| D2008A | In distribution | ||
| D1013 | In distribution | ||
| 9428NC | 288 | In distribution | |
| 29442N | 7 | In distribution | |
| 9157N | 156 | In distribution | |
| 45274TNS | 24 | In distribution | |
| 47258TNS | 6 | In distribution | |
| 43637TNS | 8 | In distribution | |
| TB29669N | 20 | In distribution | |
| 29439 | In distribution | ||
| 47154TNS | 8 | In distribution | |
| 2059N | 500 | In distribution | |
| 43548TNS | 8 | In distribution | |
| D1072NS | 100 | In distribution | |
| D1092NS | 100 | In distribution | |
| 9162 | In distribution | ||
| 46087TNS | 10 | In distribution | |
| C2299 | In distribution | ||
| 47006NS | 30 | In distribution | |
| D2288C | In distribution | ||
| D1089 | In distribution | ||
| C29474 | In distribution | ||
| 43328MNS | 8 | In distribution | |
| 47076TNS | 8 | In distribution | |
| D1030 | In distribution | ||
| 43627MNS | 8 | In distribution | |
| 29420 | In distribution | ||
| 49481TNS | 6 | In distribution | |
| D2399NS | 30 | In distribution | |
| 44236TNS | 12 | In distribution | |
| 9154N | 22 | In distribution | |
| 47011TNS | 10 | In distribution | |
| 44304MNS | 6 | In distribution | |
| 43689NS | 10 | In distribution | |
| 8482N | 70 | In distribution | |
| 49160MNS | 7 | In distribution | |
| 9430NB | 336 | In distribution | |
| 8520N | 15,000 | In distribution | |
| 29467NB | 684 | In distribution | |
| 44281TNS | 6 | In distribution | |
| C29436 | In distribution | ||
| 9165 | In distribution | ||
| C2357 | In distribution | ||
| D1030NS | 100 | In distribution | |
| 48107MNS | 8 | In distribution | |
| C29560 | In distribution | ||
| 8430N | 20 | In distribution | |
| 45262TNS | 12 | In distribution | |
| 9454 | 2 | In distribution | |
| 29440 | In distribution | ||
| 43542TNS | 8 | In distribution | |
| 9162N | 7 | In distribution | |
| 49385TNS | 10 | In distribution | |
| 59274N | 10 | In distribution | |
| 49333TNS | 5 | In distribution | |
| 46141MNS | 50 | In distribution | |
| 29468N | 30 | In distribution | |
| 41102MNS | 6 | In distribution | |
| C9444 | In distribution | ||
| ME28984 | 200 | In distribution | |
| 47242TNS | 6 | In distribution | |
| C9461 | In distribution | ||
| C2324 | In distribution | ||
| 44210TNS | 4 | In distribution | |
| 45314MNS | 6 | In distribution | |
| 43580TNS | 8 | In distribution | |
| D1020 | In distribution | ||
| D2355NS | 30 | In distribution | |
| 48196TNS | 6 | In distribution | |
| 8720N | 240 | In distribution | |
| C2315NS | 40 | In distribution | |
| 43474TNS | 10 | In distribution | |
| 43014TNS | 8 | In distribution | |
| 49632TNS | 5 | In distribution | |
| 29663N | 28 | In distribution | |
| 48256NS | 4 | In distribution | |
| C2326NS | 200 | In distribution | |
| 43491TNS | 10 | In distribution | |
| 43594TNS | 6 | In distribution | |
| 43480TNS | 10 | In distribution | |
| 47156TNS | 5 | In distribution | |
| 29472N | 55 | In distribution | |
| 47254TNS | 35 | In distribution | |
| 9157 | In distribution | ||
| 29510 | In distribution | ||
| 43743TNS | 10 | In distribution | |
| 29494N | 50 | In distribution | |
| 44181TNS | 6 | In distribution | |
| 29430 | In distribution | ||
| 45261TNS | 10 | In distribution | |
| 46138TNS | 6 | In distribution | |
| 8152N | 500 | In distribution | |
| 7553 | In distribution | ||
| 45291MNS | 6 | In distribution | |
| 45246TNS | 6 | In distribution | |
| 74210 | In distribution | ||
| 48198NS | 8 | In distribution | |
| 47060TNS | 8 | In distribution | |
| 9457 | In distribution | ||
| 29461 | In distribution | ||
| 45157TNS | 5 | In distribution | |
| D1015 | In distribution | ||
| C2324NS | 100 | In distribution | |
| 8339NA | 2,160 | In distribution | |
| 3520 | In distribution | ||
| 46124NS | 6 | In distribution | |
| 29770NS | Width 124 in | 180 | In distribution |
| D1012NS | 100 | In distribution | |
| 48018MNS | 10 | In distribution | |
| C2299NS | 100 | In distribution | |
| D1013NS | 100 | In distribution | |
| D2043 | In distribution | ||
| 44245NS | 40 | In distribution | |
| 47144TNS | 6 | In distribution | |
| 45167TNS- | 10 | In distribution | |
| D2224 | In distribution | ||
| 9133 | In distribution | ||
| 49404NS | 8 | In distribution | |
| 29439NB | 192 | In distribution | |
| 43002N | 1,000 | In distribution | |
| 29442 | In distribution | ||
| 43188MNS | 12 | In distribution | |
| 46148MNS | 6 | In distribution | |
| 9448 | In distribution | ||
| 9349NB | 1,080 | In distribution | |
| 29417N | 8 | In distribution | |
| 8184NA | 1,300 | In distribution | |
| 49435TNS | 8 | In distribution | |
| 29300N | 8 | In distribution | |
| D2008NS | 200 | In distribution | |
| D2366 | In distribution | ||
| 29458 | In distribution | ||
| D2344 | In distribution | ||
| 47170TNS | 50 | In distribution | |
| 45347NS | 20 | In distribution | |
| 8198N | In distribution | ||
| 44287TNS | 6 | In distribution | |
| 8188NC | 418 | In distribution | |
| 43483TNS | 12 | In distribution | |
| 29496NC | 340 | In distribution | |
| 9156N | 7 | In distribution | |
| 29494 | In distribution | ||
| 9423 | In distribution | ||
| 8433 | In distribution | ||
| 8486 | In distribution | ||
| 47244NS | 8 | In distribution | |
| 29436NC | 660 | In distribution | |
| D1017NS | 50 | In distribution | |
| 45291MNS | 6 | In distribution | |
| 43632MNS | 20 | In distribution | |
| 29452NC | 352 | In distribution | |
| 47223TNS | 6 | In distribution | |
| 47187TNS | 8 | In distribution | |
| 49459TNS | 8 | In distribution | |
| C2348 | In distribution | ||
| C2304 | In distribution | ||
| 9458 | In distribution | ||
| 45219TNS | 6 | In distribution | |
| 43260TNS | 10 | In distribution | |
| 5550- | 300 | In distribution | |
| 8486NA | 1,392 | In distribution | |
| D1067 | In distribution | ||
| 45208TNS | 6 | In distribution | |
| 43127TNS | 140 | In distribution | |
| 48229TNS | 8 | In distribution | |
| 8474 | In distribution | ||
| 43298TNS | 30 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | O&M Halyard, Inc. | 826 |
| Medline-Microtek | Microtek Medical LLC | 512 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 493 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 434 |
| Medline | Medline Industries, Inc. | 368 |
| Cardinal Health | Cardinal Health 200, LLC | 241 |
| Beaver Visitec Inter | GRI Medical & Electronic Technology Co., Ltd. | 179 |
| Steri-Drape™ | 3M Company | 177 |
| Halyard | Owens & Minor Distribution, Inc. | 136 |
| Microtek | Microtek Medical LLC | 101 |
| Medline Industries, Inc. | Medline Industries, Inc. | 87 |
| Halyard | GRI Medical & Electronic Technology Co., Ltd. | 83 |
Showing 12 of 305. All products under Drape, Surgical, Exempt
Recalls
10 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 |
|---|---|---|---|---|---|
| 2021-05-21 | Class II | Nonconforming Material/Component | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster | 26250 units | 2024-01-08 |
| 2021-05-21 | Class II | Nonconforming Material/Component | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster | 5342 units | 2024-01-08 |
| 2021-05-21 | Class II | Nonconforming Material/Component | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster | 1638 units | 2024-01-08 |
| 2021-05-21 | Class II | Nonconforming Material/Component | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster | 13426 units | 2024-01-08 |
| 2021-05-21 | Class II | Nonconforming Material/Component | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster | 3192 units | 2024-01-08 |
| 2021-05-21 | Class II | Nonconforming Material/Component | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster | 574 units | 2024-01-08 |
| 2021-05-21 | Class II | Nonconforming Material/Component | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster | 15360 units | 2024-01-08 |
| 2021-05-21 | Class II | Nonconforming Material/Component | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-ster | 6461 units | 2024-01-08 |
| 2021-02-25 | Class II | Nonconforming Material/Component | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly. | 83213 units | 2024-01-09 |
| 2021-02-25 | Class II | Nonconforming Material/Component | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly. | 936 units | 2024-01-09 |
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.