Ceros
Ceros Flush Syringe, Sterile Field, 10 mL USP Sodium Chloride Injection Fill in 10 mL Syringe, Sterile, Non Pyrogenic, DEHP Free, Latex Free, PVC Free
10manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2), Anhui (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiaxing Tianhe Pharmaceutical Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Suzhou Cnnc Huadong Radiation Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Lucky Star Lrradiation Science Co., Ltd. Shanghai | Shanghai | Shanghai | Contract manufacturer | 5 |
| Anhui Tianyang Pharmaceutical Co., Ltd. | Tianchang | Anhui | Manufacturer | 1 |
Record
| Listed by | Rhino Medical Supply Inc, United States |
|---|---|
| FDA product code | NGT |
| Device type | Saline, Vascular Access Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Repacker / relabeller |
| 510(k) | K230756 |
| Record published | 2024-03-18 |
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 | Inner box of 30, inner box of 100, shipper case of 20, shipper case of 10, shipper case of 4, case of 4 |
| Sizes | Total volume 3 to 10 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RM-PF0303 | Total Volume 3 ml | In distribution |
| RM-PF1210 | Total Volume 10 ml | In distribution |
| RM-PF1010SF | Total Volume 10 ml | In distribution |
| RM-PF1010 | Total Volume 10 ml | In distribution |
| RM-PF1210SF | Total Volume 10 ml | In distribution |
| RM-PF1203 | Total Volume 3 ml | In distribution |
| RM-PF0505 | Total Volume 5 ml | In distribution |
| RM-PF1205 | Total Volume 5 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Excelsior | Medline Industries, Inc. | 28 |
| AMSafe® Pre-Filled Normal Saline Flush Syringe | Amsino Medical Inc. | 25 |
| Monoject | Cardinal Health | 19 |
| Nurse Assist | Nurse Assist, LLC | 13 |
| Praxiject™ 0.9% NaCl | MedXL | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Normal Saline IV Flush Syringe | Medefil, Inc. | 6 |
| Easy Flush | SPM Medicare PVT, Ltd. | 6 |
| Covidien | Nurse Assist, LLC | 6 |
| Gbuk | Jiangsu Caina Medical Co., Ltd. | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Halyard | O&M Halyard, Inc. | 4 |
Showing 12 of 35. All products under Saline, Vascular Access Flush
Recalls Naming This Product
3 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 | Closed |
|---|---|---|---|---|---|---|---|
| Nurse Assist, LLC | 510(k) number | 2023-11-06 | Class I | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | 61,740 Cases | |
| Nurse Assist, LLC | 510(k) number | 2023-11-06 | Class I | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | 3,360 Cases | |
| Nurse Assist, LLC | 510(k) number | 2016-10-04 | Class I | Unknown/Undetermined by firm | Potential contamination with B. cepacia. | 386,175 syringes | 2017-08-16 |
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.