Namic
NAMIC Standard Peripheral Vascular Angiographic Kit Portection Station with Radiology Control Syringe and flexCIL
13manufacturers in China registered for this device type
165catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
Showing 12 of 13. All 13 manufacturers in China registered for Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Record
| Listed by | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | DTL |
| Device type | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4290 |
| 510(k) | K842829 |
| Record published | 2015-09-17 |
| Record revised | 2021-04-07 (version 5) |
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 100, box of 50, box of 5, box of 500, box of 10 |
| Sizes | Pressure 200 to 1050 psi; lumen/inner diameter 0.1 to 0.125 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80037313 | In distribution | |
| 70037404 | In distribution | |
| 91301303 | In distribution | |
| 80620561 | In distribution | |
| 80035008 | Pressure 400 psi | In distribution |
| 80035002 | Pressure 400 psi | In distribution |
| 91301301 | In distribution | |
| 70055003 | Pressure 1050 psi | In distribution |
| 70036301 | In distribution | |
| 81400123 | Lumen/Inner Diameter 0.113 in | In distribution |
| 80515112 | Pressure 400 psi | In distribution |
| 80037202 | In distribution | |
| 70039404 | In distribution | |
| 64038200 | In distribution | |
| 80800003 | In distribution | |
| 80036301 | In distribution | |
| 84038301 | In distribution | |
| 70035003 | In distribution | |
| 80055009 | Pressure 1050 psi | In distribution |
| 70036200 | In distribution | |
| 80038402 | In distribution | |
| 64038303 | In distribution | |
| 91400031 | Lumen/Inner Diameter 0.1 in | In distribution |
| 70038313 | In distribution | |
| 64000124 | Lumen/Inner Diameter 0.113 in | In distribution |
| 64000222 | Lumen/Inner Diameter 0.1 in | In distribution |
| 80055003 | Pressure 1050 psi | In distribution |
| 70039212 | In distribution | |
| 91310230 | In distribution | |
| 80037200 | In distribution | |
| 80027180 | In distribution | |
| 80038404 | In distribution | |
| 80036202 | In distribution | |
| 70015013 | In distribution | |
| 70039402 | In distribution | |
| 80037402 | In distribution | |
| 64000223 | Lumen/Inner Diameter 0.113 in | In distribution |
| 70036202 | In distribution | |
| 64000227 | Lumen/Inner Diameter 0.113 in | In distribution |
| 80435002 | Pressure 500 psi | In distribution |
| 80055008 | Pressure 1050 psi | In distribution |
| 80039212 | In distribution | |
| 70015003 | In distribution | |
| 64000925 | 1000 ml | In distribution |
| 80039313 | In distribution | |
| 70027180 | In distribution | |
| 70038301 | In distribution | |
| 70055017 | Pressure 1050 psi | In distribution |
| 70038212 | In distribution | |
| 80015016 | Pressure 200 psi | In distribution |
| 84038404 | In distribution | |
| 64038402 | In distribution | |
| 80039301 | In distribution | |
| 80038200 | In distribution | |
| 70035009 | In distribution | |
| 80601005 | Pressure 1050 psi | In distribution |
| 70015001 | In distribution | |
| 70038404 | In distribution | |
| 80015000 | Pressure 200 psi | In distribution |
| 64000224 | Lumen/Inner Diameter 0.113 in | In distribution |
| 70015015 | In distribution | |
| 70039352 | In distribution | |
| 80015003 | Pressure 200 psi | In distribution |
| 70037202 | In distribution | |
| 64000123 | Lumen/Inner Diameter 0.113 in | In distribution |
| 84038303 | In distribution | |
| 80015012 | Pressure 200 psi | In distribution |
| 80039303 | In distribution | |
| 80038212 | In distribution | |
| 91400221 | Lumen/Inner Diameter 0.1 in | In distribution |
| 91400235 | Lumen/Inner Diameter 0.125 in | In distribution |
| 80015013 | Pressure 200 psi | In distribution |
| 91400025 | Lumen/Inner Diameter 0.125 in | In distribution |
| 84038202 | In distribution | |
| 64038404 | In distribution | |
| 70038200 | In distribution | |
| 80038303 | In distribution | |
| 64038301 | In distribution | |
| 70038402 | In distribution | |
| 70055009 | Pressure 1050 psi | In distribution |
| 806010017 | In distribution | |
| 80038301 | In distribution | |
| 81400025 | Lumen/Inner Diameter 0.125 in | In distribution |
| 70037212 | In distribution | |
| 80751003 | In distribution | |
| 70035013 | In distribution | |
| 80036200 | In distribution | |
| 70035008 | In distribution | |
| 70015002 | In distribution | |
| 70039353 | In distribution | |
| 91400023 | Lumen/Inner Diameter 0.1 in | In distribution |
| 70036303 | In distribution | |
| 80015010 | Pressure 200 psi | In distribution |
| 80516901 | Pressure 200 psi | In distribution |
| 80015015 | Pressure 200 psi | In distribution |
| 80751000 | In distribution | |
| 80037404 | In distribution | |
| 80055017 | Pressure 1050 psi | In distribution |
| 80519831 | In distribution | |
| 70015012 | In distribution | |
| 806010016 | In distribution | |
| 80036303 | In distribution | |
| 91400231 | Lumen/Inner Diameter 0.1 in | In distribution |
| 70037414 | In distribution | |
| 70039200 | In distribution | |
| 91400225 | Lumen/Inner Diameter 0.125 in | In distribution |
| 70039355 | In distribution | |
| 91310200 | In distribution | |
| 64000122 | Lumen/Inner Diameter 0.1 in | In distribution |
| 70039202 | In distribution | |
| 64038202 | In distribution | |
| 70038414 | In distribution | |
| 91310210 | In distribution | |
| 91400028 | Lumen/Inner Diameter 0.125 in | In distribution |
| 70015016 | In distribution | |
| 91400021 | Lumen/Inner Diameter 0.1 in | In distribution |
| 70039303 | In distribution | |
| 80038313 | In distribution | |
| 80035013 | Pressure 400 psi | In distribution |
| 70039301 | In distribution | |
| 70035012 | In distribution | |
| 80515351 | Pressure 200 psi | In distribution |
| 70038202 | In distribution | |
| 70055008 | Pressure 1050 psi | In distribution |
| 80015002 | Pressure 200 psi | In distribution |
| 80038202 | In distribution | |
| 91400035 | Lumen/Inner Diameter 0.125 in | In distribution |
| 80750000 | In distribution | |
| 80039202 | In distribution | |
| 70037301 | In distribution | |
| 70039414 | In distribution | |
| 81400021 | Lumen/Inner Diameter 0.1 in | In distribution |
| 70037313 | In distribution | |
| 64000001 | In distribution | |
| 80037414 | In distribution | |
| 80751004 | In distribution | |
| 91310310 | In distribution | |
| 70015000 | In distribution | |
| 80035009 | Pressure 400 psi | In distribution |
| 91310330 | In distribution | |
| 80039352 | In distribution | |
| 91310220 | In distribution | |
| 70037200 | In distribution | |
| 70015011 | In distribution | |
| 84038402 | In distribution | |
| 70038303 | In distribution | |
| 80037303 | In distribution | |
| 91310320 | In distribution | |
| 806010014 | In distribution | |
| 91400228 | Lumen/Inner Diameter 0.125 in | In distribution |
| 70035002 | In distribution | |
| 80039200 | In distribution | |
| 64000127 | Lumen/Inner Diameter 0.113 in | In distribution |
| 70037402 | In distribution | |
| 806010015 | In distribution | |
| 80516592 | Lumen/Inner Diameter 0.1 in | In distribution |
| 80037301 | In distribution | |
| 80037212 | In distribution | |
| 70037303 | In distribution | |
| 70015010 | In distribution | |
| 64000270 | In distribution | |
| 91310300 | In distribution | |
| 70039313 | In distribution | |
| 84038200 | In distribution | |
| 80800002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 171 |
| Namic | Medline Industries, Inc. | 170 |
| Merit® Manifold | Merit Medical Systems, Inc. | 119 |
| Connector | LivaNova USA, Inc. | 70 |
| Medline Industries, Inc. | Medline Industries, Inc. | 62 |
| Demax | Beijing Demax Medical Technology Co., Ltd. | 60 |
| DLP® | Medtronic, Inc. | 51 |
| Marquis® Stopcock | Merit Medical Systems, Inc. | 40 |
| Cook | Cook Incorporated | 38 |
| Unbranded | Advance Medical Designs, Inc. | 30 |
| Contrast Line | Argon Medical Devices, Inc. | 25 |
| INT | Shanghai Kindly Medical Instruments Co., Ltd. | 18 |
Showing 12 of 127. All products under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091634 | 2010-03-01 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2026-03-24 | Class I | Under Investigation by firm | Medline has identified the presence of particulate within the fluid path of the Manifolds. | 7075 units | |
| Medline Industries, LP – Northfield | 510(k) number | 2026-03-24 | Class I | Under Investigation by firm | Medline has identified the presence of particulate within the fluid path of the Manifolds. | 38175 units | |
| Medline Industries, LP – Northfield | 510(k) number | 2026-03-24 | Class I | Under Investigation by firm | Medline has identified the presence of particulate within the fluid path of the Manifolds. | 1975 units | |
| Medline Industries, LP – Northfield | 510(k) number | 2021-08-06 | Class II | Process design | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions. | 816,420 manifolds and stopcocks | 2025-08-25 |
| Medline Industries, LP – Northfield | 510(k) number | 2021-08-06 | Class II | Process design | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions. | 816,420 manifolds and stopcocks | 2025-08-25 |
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.