Namic
MTO Protection Sta.w/Bif.saline Line PG
49manufacturers in China registered for this device type
43catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Record published | 2021-07-26 |
| Record revised | 2024-10-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25, box of 10, box of 5, box of 20 |
| Sizes | Length 48 to 135 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 91300009 | Length 108 in | In distribution | |
| 90500070 | In distribution | ||
| 80427035 | FALSE | 150 | In distribution |
| 90500060 | Length 72 in | In distribution | |
| 99000070 | Length 135 in | In distribution | |
| 80427009 | FALSE | 150 | In distribution |
| 91300007 | Length 108 in | In distribution | |
| 94000904 | In distribution | ||
| 99000069 | Length 135 in | In distribution | |
| 64000936 | In distribution | ||
| 80015221 | FALSE | 100 | In distribution |
| 91300005 | Length 72 in | In distribution | |
| 80400039 | FALSE | 100 | In distribution |
| 64000944 | In distribution | ||
| 94000954 | In distribution | ||
| 64000130 | In distribution | ||
| 64000935 | In distribution | ||
| 80029130 | FALSE | 150 | In distribution |
| 91300026 | Length 72 in | In distribution | |
| 80518491 | FALSE | 250 | In distribution |
| 80427013 | FALSE | 150 | In distribution |
| 80427007 | FALSE | 150 | In distribution |
| 91300035 | Length 72 in | In distribution | |
| 91300021 | Length 72 in | In distribution | |
| 91300013 | Length 48 in | In distribution | |
| 91300004 | Length 72 in | In distribution | |
| 80427040 | FALSE | 150 | In distribution |
| 91300040 | Length 72 in | In distribution | |
| 64000934 | In distribution | ||
| 80427026 | FALSE | 50 | In distribution |
| 90500065 | In distribution | ||
| 94000952 | In distribution | ||
| 80427006 | FALSE | 150 | In distribution |
| 81300021 | FALSE | 100 | In distribution |
| 91300012 | Length 48 in | In distribution | |
| 80427440 | FALSE | 150 | In distribution |
| 91300001 | Length 48 in | In distribution | |
| 64000945 | In distribution | ||
| 80427004 | FALSE | 150 | In distribution |
| 91300052 | Length 72 in | In distribution | |
| 91300011 | Length 48 in | In distribution | |
| 91300020 | In distribution | ||
| 80427052 | FALSE | 150 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170002 | 2017-09-19 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-12-16 | Class I | Under Investigation by firm | Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber. | 13,600 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-12 | Class II | Process control | Products have a lack of sterility assurance. | 50 units |
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.