Spectraline™
9 catalogue numbers from 00884450671672, listed by Merit Medical Systems, Inc., United States, under Syringe, Piston. 60 manufacturers in China are registered for this product code.
60manufacturers in China registered for this device type
9catalogue numbers in this listing
10510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2025-08-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 4, pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450671672 | In distribution | |
| 00884450671665 | In distribution | |
| 00884450671658 | In distribution | |
| 00884450671641 | In distribution | |
| 00884450671696 | In distribution | |
| 00884450671689 | In distribution | |
| 00884450671634 | In distribution | |
| 00884450671603 | In distribution | |
| 00884450671610 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 228 |
| Medallion® | Merit Medical Systems, Inc. | 223 |
| Merit Medical® | Merit Medical Systems, Inc. | 192 |
| Monoject | Cardinal Health | 188 |
| Medline | Medline Industries, Inc. | 127 |
| EasyTouch | MHC Medical Products | 122 |
| Medline Industries, Inc. | Medline Industries, Inc. | 99 |
| Arrow | Teleflex Medical LLC | 94 |
| Ceros | Rhino Medical Supply Inc | 92 |
| Enteral Feeding | Medela LLC | 87 |
| Monoject | Cardinal Health 200, LLC | 83 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
Showing 12 of 913. All products under Syringe, Piston
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250853 | 2025-11-04 |
| K182216 | 2018-11-06 |
| K182279 | 2018-11-06 |
| K173601 | 2018-01-31 |
| K171362 | 2017-08-07 |
| K152783 | 2015-12-07 |
| K142636 | 2014-10-17 |
| K111091 | 2011-06-24 |
| K024052 | 2003-02-21 |
| K994253 | 2000-01-05 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2018-02-02 | Class II | Nonconforming Material/Component | Supplier manufacturing defect with the syringe plunger tip. | 22,234 | 2020-11-30 |
| 2017-03-23 | Class II | Nonconforming Material/Component | Merit Medical Systems announces a voluntary field action for the 1mL Medallion Syringes due to a defect with the syringe plunger tip. | 23,032 units | 2017-09-26 |
| 2014-03-13 | Class II | Release of Material/Component prior to receiving test results | The products are labeled as sterile but were not sterilized. | 15 | 2014-07-07 |
| 2010-10-22 | Not classified | Packaging process control | Packaging for syringes may have holes which would compromise the sterility of the package contents. | 49 units | 2011-01-18 |
| 2010-10-22 | Not classified | Packaging process control | Packaging for syringes may have holes which would compromise the sterility of the package contents. | 97 units | 2011-01-18 |
| 2010-10-22 | Not classified | Packaging process control | Packaging for syringes may have holes which would compromise the sterility of the package contents. | 25 units | 2011-01-18 |
| 2010-10-22 | Not classified | Packaging process control | Packaging for syringes may have holes which would compromise the sterility of the package contents. | 789 units | 2011-01-18 |
| 2010-09-09 | Not classified | Employee error | Small holes in the packaging may render the product non-sterile. | 10,000 units | 2011-03-21 |
| 2010-09-09 | Not classified | Employee error | Small holes in the packaging may render the product non-sterile. | 2337 units | 2011-03-21 |
| 2010-09-09 | Not classified | Employee error | Small holes in the packaging may render the product non-sterile. | 199 units | 2011-03-21 |
| 2010-09-09 | Not classified | Employee error | Small holes in the packaging may render the product non-sterile. | 746 units | 2011-03-21 |
| 2010-09-09 | Not classified | Employee error | Small holes in the packaging may render the product non-sterile. | 2993 units | 2011-03-21 |
| 2010-09-09 | Not classified | Employee error | Small holes in the packaging may render the product non-sterile. | 299 units | 2011-03-21 |
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 25 syringes | 2009-12-15 |
| 2008-07-09 | Not classified | Process control | Control Syringes may be non-sterile due to holes in the packaging. | 100 units | 2008-11-03 |
| 2008-07-09 | Not classified | Process control | Control Syringes may be non-sterile due to holes in the packaging. | 679 units | 2008-11-03 |
| 2008-07-09 | Not classified | Process control | Control Syringes may be non-sterile due to holes in the packaging. | 519 units | 2008-11-03 |
| 2004-09-14 | Not classified | Other | Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch. | 25 syringes | 2005-03-31 |
| 2003-10-01 | Not classified | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated t | 287 units | 2004-02-02 |
| 2003-05-16 | Not classified | Other | Cracks in the syringe barrels could allow for air aspiration into the syringe barrel. | 7257 units | 2003-07-21 |
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.