Medrad® Pres
Assy, TBG, Pres 50, MC (86990679)
49manufacturers in China registered for this device type
1catalogue number
11recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | Bayer Medical Care Inc., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083723 |
| Record published | 2021-04-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRES50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
Recalls Naming This Product
65 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 36,552 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 10,536 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 88,200 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 58,752 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 24,648 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 7,344 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 24,624 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 164,568 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 7,240 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 12,225,913 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 2,871,707 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 381,850 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 11,650 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 30,250 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 1,200 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 66,792 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 18,984 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 1,861,111 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 80,650 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 65,904 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 224,856 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 29,900 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 129,480 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 1,272 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 259,392 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 6,768 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 19,104 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 11,832 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 40,992 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 286,400 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 126,050 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 226,632 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 10,896 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 28,344 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 25,728 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 32,304 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 24,072 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 45,288 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 41,976 units |
| B. Braun Medical Inc. | 510(k) number | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 2,544 units |
Showing 40 of 65.
Recalls
11 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 |
|---|---|---|---|---|---|
| 2018-09-07 | Class II | Nonconforming Material/Component | Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path. | 1,142,836 (329,944 units in U.S.) | 2019-07-11 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
| 2012-04-18 | Class II | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating th | 1,229 Pumps total | 2015-08-17 |
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.