Namic
MTO Manifold Morse CL.4V 200 RH/OFF-PKG
13manufacturers in China registered for this device type
170catalogue 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | DTL |
| Device type | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4290 |
| Premarket notification | Exempt |
| Record published | 2022-02-23 |
| Record revised | 2024-11-11 (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 |
| Storage | Special storage condition: Keep dry. |
| Packaging | Box of 25, box of 50, box of 5, box of 10, case of 25, case of 10 |
| Sizes | Lumen/inner diameter 0.1 in; pressure 1050 psi |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 64038402 | In distribution | ||
| 91400225 | In distribution | ||
| 806010015 | FALSE | 100 | In distribution |
| 80055009 | FALSE | 100 | In distribution |
| 70038303 | In distribution | ||
| 70039404 | In distribution | ||
| 64038200 | In distribution | ||
| 80027180 | FALSE | 500 | In distribution |
| 80015012 | FALSE | 500 | In distribution |
| 806010016 | FALSE | 100 | In distribution |
| 64000925 | In distribution | ||
| 80037212 | FALSE | 100 | In distribution |
| 70039301 | In distribution | ||
| 70027180 | In distribution | ||
| 80037402 | FALSE | 100 | In distribution |
| 64038202 | In distribution | ||
| 64038404 | In distribution | ||
| 70015003 | In distribution | ||
| 80038202 | FALSE | 100 | In distribution |
| 80751004 | FALSE | 10,000 | In distribution |
| 91310200 | In distribution | ||
| 70035002 | In distribution | ||
| 80516592 | FALSE | 500 | In distribution |
| 80435002 | FALSE | 500 | In distribution |
| 70038202 | In distribution | ||
| 80751003 | FALSE | 10,000 | In distribution |
| 80037404 | FALSE | 100 | In distribution |
| 64000227 | In distribution | ||
| 80037200 | FALSE | 100 | In distribution |
| 80055003 | FALSE | 100 | In distribution |
| 91400031 | Lumen/Inner Diameter 0.1 in | In distribution | |
| 84038402 | FALSE | 100 | In distribution |
| 80037202 | FALSE | 100 | In distribution |
| 80038212 | FALSE | 100 | In distribution |
| 70039402 | In distribution | ||
| 70015012 | In distribution | ||
| 84038303 | FALSE | 100 | In distribution |
| 70037402 | In distribution | ||
| 70015010 | In distribution | ||
| 80015015 | FALSE | 500 | In distribution |
| 70035003 | In distribution | ||
| 80039313 | FALSE | 100 | In distribution |
| 70039200 | In distribution | ||
| 91400231 | Lumen/Inner Diameter 0.1 in | In distribution | |
| 64038303 | In distribution | ||
| 70037404 | In distribution | ||
| 70055017 | Pressure 1050 psi | In distribution | |
| 80038404 | FALSE | 100 | In distribution |
| 70055008 | Pressure 1050 psi | In distribution | |
| 80039212 | FALSE | 100 | In distribution |
| 80620561 | FALSE | 500 | In distribution |
| 64000223 | In distribution | ||
| 80035009 | FALSE | 100 | In distribution |
| 70039353 | In distribution | ||
| 70015016 | In distribution | ||
| 80036303 | FALSE | 50 | In distribution |
| 80601005 | FALSE | 100 | In distribution |
| 64000122 | In distribution | ||
| 84038301 | FALSE | 100 | In distribution |
| 64038301 | In distribution | ||
| 64000123 | In distribution | ||
| 80038303 | FALSE | 100 | In distribution |
| 70039355 | In distribution | ||
| 91310230 | In distribution | ||
| 80515351 | FALSE | 500 | In distribution |
| 70015011 | In distribution | ||
| 91400035 | In distribution | ||
| 80038200 | FALSE | 100 | In distribution |
| 80038402 | FALSE | 100 | In distribution |
| DYNJCAPM2 | In distribution | ||
| 70039202 | In distribution | ||
| 91400235 | In distribution | ||
| 80015013 | FALSE | 500 | In distribution |
| 91400028 | In distribution | ||
| 70015013 | In distribution | ||
| 80055008 | FALSE | 100 | In distribution |
| 91310330 | In distribution | ||
| 80037301 | FALSE | 100 | In distribution |
| 70036200 | In distribution | ||
| 70036303 | In distribution | ||
| 80037303 | FALSE | 100 | In distribution |
| 70039313 | In distribution | ||
| 80800002BX | FALSE | 5,000 | In distribution |
| 70055009 | Pressure 1050 psi | In distribution | |
| 80036301 | FALSE | 50 | In distribution |
| 70037313 | In distribution | ||
| 70038200 | In distribution | ||
| 80039301 | FALSE | 100 | In distribution |
| 70035008 | In distribution | ||
| 80750000 | FALSE | 100 | In distribution |
| 81400021 | FALSE | 250 | In distribution |
| 70037303 | In distribution | ||
| 70036301 | In distribution | ||
| 80037414 | FALSE | 100 | In distribution |
| 64000270 | In distribution | ||
| 91400228 | In distribution | ||
| 84038404 | FALSE | 100 | In distribution |
| 91400023 | Lumen/Inner Diameter 0.1 in | In distribution | |
| 80035008 | FALSE | 100 | In distribution |
| 70037414 | In distribution | ||
| 80015000 | FALSE | 500 | In distribution |
| DYNJCAPBCS | 1,000 | In distribution | |
| 70037212 | In distribution | ||
| 91310310 | In distribution | ||
| 70037202 | In distribution | ||
| 91301301 | In distribution | ||
| 70038313 | In distribution | ||
| 80015003 | FALSE | 500 | In distribution |
| 64000001 | In distribution | ||
| 80055017 | FALSE | 100 | In distribution |
| 64000222 | In distribution | ||
| 80039202 | FALSE | 100 | In distribution |
| 70015001 | In distribution | ||
| 70038402 | In distribution | ||
| 70035013 | In distribution | ||
| 70039414 | In distribution | ||
| 80036202 | FALSE | 50 | In distribution |
| DYNJYPUSH | In distribution | ||
| 80038301 | FALSE | 100 | In distribution |
| 80039200 | FALSE | 100 | In distribution |
| 80037313 | FALSE | 100 | In distribution |
| 80015010 | FALSE | 500 | In distribution |
| 91400021 | Lumen/Inner Diameter 0.1 in | In distribution | |
| 70038414 | In distribution | ||
| 80035002 | FALSE | 500 | In distribution |
| 806010014 | FALSE | 100 | In distribution |
| 91310320 | In distribution | ||
| 80516901 | FALSE | 500 | In distribution |
| 91310300 | In distribution | ||
| 84038202 | FALSE | 100 | In distribution |
| 80036200 | FALSE | 50 | In distribution |
| 91400221 | Lumen/Inner Diameter 0.1 in | In distribution | |
| 70039354 | In distribution | ||
| 70037301 | In distribution | ||
| 80038313 | FALSE | 100 | In distribution |
| 90500018 | In distribution | ||
| 70015002 | In distribution | ||
| 80039352 | FALSE | 100 | In distribution |
| 70035009 | In distribution | ||
| 70039212 | In distribution | ||
| 80035013 | FALSE | 500 | In distribution |
| 81400123 | FALSE | 250 | In distribution |
| 84038200 | FALSE | 100 | In distribution |
| 70035012 | In distribution | ||
| 64000127 | In distribution | ||
| 64000124 | In distribution | ||
| 80519831 | FALSE | 10,000 | In distribution |
| 80039303 | FALSE | 100 | In distribution |
| 70038212 | In distribution | ||
| 70039352 | In distribution | ||
| 91310210 | In distribution | ||
| 80800003BX | FALSE | 5,000 | In distribution |
| 70015015 | In distribution | ||
| 70036202 | In distribution | ||
| 70038301 | In distribution | ||
| 81400025 | FALSE | 250 | In distribution |
| 80015002 | FALSE | 500 | In distribution |
| 70039303 | In distribution | ||
| 91310220 | In distribution | ||
| 70037200 | In distribution | ||
| 70015000 | In distribution | ||
| 70038404 | In distribution | ||
| 70055003 | Pressure 1050 psi | In distribution | |
| 80015016 | FALSE | 500 | In distribution |
| 91400025 | In distribution | ||
| 806010017 | FALSE | 100 | In distribution |
| 80751000 | FALSE | 10,000 | In distribution |
| 91301303 | In distribution | ||
| 80515112 | FALSE | 500 | In distribution |
| 64000224 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 171 |
| Namic | Navilyst Medical, Inc. | 165 |
| 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 |
|---|---|
| K120069 | 2012-04-03 |
Recalls Naming This Product
3 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 | 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 | UDI-DI | 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 | UDI-DI | 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 |
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.