MaxGuard
3-Port manifold with 3 integrated antisiphon valves, 1 back check valve, 4-way stopcock and needleless Y-extension 91 cm (36 in)
49manufacturers in China registered for this device type
150catalogue numbers in this listing
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 | BD Switzerland Sàrl |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Record published | 2016-09-22 |
| Record revised | 2024-07-23 (version 8) |
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 |
| Storage | Special storage condition: Keep dry; Special storage condition: Storage Temperature; Storage environment temperature -40 to 125 °F; Special storage condition: Fragile, handle with care; Special storage condition: Keep away from sunlight |
| Packaging | Case of 50, box of 50, case of 25, case of 12, pack or inner pack of 50, case of 600 |
| Sizes | Length 4 to 166 in; total volume 0.27 to 2 ml |
| Distribution end date | 2024-01-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MXT1006 | Length 5.5 in | In distribution |
| MC3500 | Length 40 in | In distribution |
| ME1050 | Length 30 in | In distribution |
| MX4471 | Length 32 in | In distribution |
| ME2069 | Length 60 in | In distribution |
| M4026 | Length 20 in | In distribution |
| M4058 | Length 36 in | In distribution |
| MFS137 | Length 74 in | In distribution |
| ME2070 | Length 60 in | In distribution |
| MA3111 | In distribution | |
| MM4300-1 | In distribution | |
| ME1226 | Length 30 in | In distribution |
| ME1047 | Length 6 in | In distribution |
| ME1257 | Length 7 in | In distribution |
| MX9412 | Length 110 in | In distribution |
| MX9076 | Length 19 in | In distribution |
| ME1048 | Length 12 in | In distribution |
| ME1213 | Length 17 in | In distribution |
| MFS142 | Length 80 in | In distribution |
| MX9037 | Total Volume 2 ml | In distribution |
| MX9414 | Length 112 in | In distribution |
| M4018 | In distribution | |
| MX4443 | In distribution | |
| MX9060 | Length 8 in | In distribution |
| MX5302 | Length 6 in | In distribution |
| MX4450 | Length 64 in | In distribution |
| MFS100 | Length 100 in | In distribution |
| MX4464 | Length 44 in | In distribution |
| ME1256 | In distribution | |
| ME1032 | Length 6 in | In distribution |
| MX9166 | Length 16 in | In distribution |
| MX9107 | Length 91 in | In distribution |
| ME1227 | Length 6 in | In distribution |
| MX4436 | Length 166 in | In distribution |
| MS3542 | In distribution | |
| MFS120 | In distribution | |
| ME1230 | Length 40 in | In distribution |
| MX9128 | Length 113 in | In distribution |
| ME1224 | In distribution | |
| MX4452 | Length 140 in | In distribution |
| MX9059 | Length 36 in | In distribution |
| MA3131 | Length 85 in | In distribution |
| MFS139 | Length 84 in | In distribution |
| ME1232 | Length 5 in | In distribution |
| ME1222 | Length 4 in | In distribution |
| ME1247 | Length 7 in | In distribution |
| MM4000 | In distribution | |
| ME1254 | Length 10 in | In distribution |
| MFS140 | Length 85 in | In distribution |
| ME5304 | Total Volume 0.4 ml | In distribution |
| MX9963 | Length 107 in | In distribution |
| ME1046 | Length 4 in | In distribution |
| ME2020 | Length 60 in | In distribution |
| MX4470 | In distribution | |
| ME2017 | Length 60 in | In distribution |
| MX9436 | In distribution | |
| ME1214 | Length 6 in | In distribution |
| ME1021 | Length 6 in | In distribution |
| ME1229 | Length 5 in | In distribution |
| ME1069 | Length 20 in | In distribution |
| MX5301 | Length 8 in | In distribution |
| ME1055 | Length 30 in | In distribution |
| ME5302 | Length 6.5 in | In distribution |
| ME1225 | Length 15 in | In distribution |
| MFS106 | Length 23 in | In distribution |
| MC3102 | Length 84 in | In distribution |
| ME2010 | Length 60 in | In distribution |
| MFS143 | Length 110 in | In distribution |
| ME1233 | Length 5 in | In distribution |
| M4060 | In distribution | |
| MFS104 | In distribution | |
| MA3127 | Length 85 in | In distribution |
| MX9416 | Length 110 in | In distribution |
| MX9172 | Length 40 in | In distribution |
| ME1223 | Length 7 in | In distribution |
| MM4021 | Length 44 in | In distribution |
| MX4465 | Length 106 in | In distribution |
| MS3101 | In distribution | |
| MX4458 | Length 135 in | In distribution |
| MFS102 | Length 99 in | In distribution |
| ME1242 | Length 40 in | In distribution |
| MX4468 | Length 44 in | In distribution |
| MY3001 | In distribution | |
| MX1002 | In distribution | |
| MFS132 | Length 89 in | In distribution |
| ME2059 | Length 72 in | In distribution |
| MX4457 | Length 19.5 in | In distribution |
| MT6000 | Length 22 in | In distribution |
| ME1028 | Total Volume 0.27 ml | In distribution |
| MX4441 | In distribution | |
| MX4050 | Length 39 in | In distribution |
| MX4449 | In distribution | |
| M4101 | Length 7 in | In distribution |
| ME1250 | Length 6 in | In distribution |
| MV0500 | In distribution | |
| ME5301 | Length 7.5 in | In distribution |
| MX4439 | Length 40 in | In distribution |
| MX9182 | Length 8 in | In distribution |
| ME1001 | Length 6 in | In distribution |
| ME1248 | Size = Priming Volume = 1 millilitre (mL) | In distribution |
| ME2064 | Total Volume 0.6 ml | In distribution |
| ME1255 | In distribution | |
| MFS124 | Length 75 in | In distribution |
| MY3004 | Length 7 in | In distribution |
| ME2050 | Length 60 in | In distribution |
| MXT1005 | Length 6 in | In distribution |
| MX9433 | Length 128 in | In distribution |
| MX4410 | Length 145 in | In distribution |
| MFS141 | Length 14 in | In distribution |
| MXT1004 | Total Volume 0.8 ml | In distribution |
| ME1110 | Length 36 in | In distribution |
| MX9968 | Length 110 in | In distribution |
| ME2068 | Length 60 in | In distribution |
| MT6004 | In distribution | |
| MA3137 | In distribution | |
| M4020 | In distribution | |
| MM4027 | Length 36 in | In distribution |
| MXT1003 | Length 6 in | In distribution |
| MX4412 | Length 90 in | In distribution |
| ME5303 | Total Volume 0.4 ml | In distribution |
| MX9171 | Length 16 in | In distribution |
| ME1217 | Length 30 in | In distribution |
| MFS134 | Withdrawn | |
| ME1180 | Withdrawn | |
| ME2071 | Withdrawn | |
| MX9411 | Withdrawn | |
| MX9165 | Withdrawn | |
| MX9185 | Withdrawn | |
| MFS135 | Withdrawn | |
| MX4416 | Withdrawn | |
| ME1246 | Withdrawn | |
| MX4463 | Withdrawn | |
| MX9181 | Withdrawn | |
| ME1251 | Withdrawn | |
| ME1234 | Withdrawn | |
| MX9164 | Withdrawn | |
| MX4462 | Withdrawn | |
| MX9431 | Withdrawn | |
| MX4440 | Withdrawn | |
| MX4469 | Withdrawn | |
| MX9424 | Withdrawn | |
| MA3139 | Withdrawn | |
| MFS121 | Withdrawn | |
| MX4467 | Withdrawn | |
| ME1253 | Withdrawn | |
| MM4028 | Withdrawn | |
| M4025 | Withdrawn | |
| MX9998 | Withdrawn | |
| M4063 | Withdrawn | |
| MV0700 | Withdrawn |
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 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
| Alaris | BD Switzerland Sàrl | 122 |
Showing 12 of 768. All products under Set, Administration, Intravascular
Recalls Naming This Product
11 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| BD Switzerland Sarl | UDI-DI | 2026-06-16 | Class II | Process control | Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly. | 93,700 |
| Becton, Dickinson & Co. | UDI-DI | 2023-10-11 | Class II | Error in labeling | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). | |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 46,900 |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 3,500 |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 54,050 |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 37,550 |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 19,925 |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 17,250 |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 600 |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 100 |
| Carefusion | UDI-DI | 2022-08-01 | Class II | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks a | 9,900 |
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.