Biosite/Biosite Plus
BI8504 Opaque Biosite Plus Neutral Pressure Needleless Valve w/14" Microbore Extension
49manufacturers in China registered for this device type
27catalogue 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 | Maclin Power, Inc., Italy |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Record published | 2018-02-14 |
| Record revised | 2018-03-29 (version 2) |
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 away from direct sunlight.; Special storage condition: Keed dry. |
| Packaging | Carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| JR-018-SU | 200 | In distribution | |
| BI8002 | 100 | In distribution | |
| JR-012-CU | 50 | In distribution | |
| BI8000 | 100 | In distribution | |
| JR-020-SU | 200 | In distribution | |
| JR-019-AU | 200 | In distribution | |
| BI8504 | 100 | In distribution | |
| JR-015-AU | 200 | In distribution | |
| JR-024-AU | 200 | In distribution | |
| JR-044-AU | 200 | In distribution | |
| JR-021-LU | 200 | In distribution | |
| JR-016-AU | 200 | In distribution | |
| JR-010-AU | 200 | In distribution | |
| JR-011-AU | 200 | In distribution | |
| JR-018-LU | 200 | In distribution | |
| JR-009-TU | 1,000 | In distribution | |
| JR-014-AU | 200 | In distribution | |
| BI8502 | 100 | In distribution | |
| JR-017-AU | 200 | In distribution | |
| JR-025-BU | 200 | In distribution | |
| JR-020-LU | 200 | In distribution | |
| JR-021-SU | 200 | In distribution | |
| BI8004 | 100 | In distribution | |
| JR-012-AU | 50 | In distribution | |
| JR-025-AU | 200 | In distribution | |
| BI8500 | 100 | In distribution | |
| JR-009-HU | 1,000 | 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 |
|---|---|
| K121511 | 2013-03-07 |
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.