Namic
DBD-MTO Manifold, Perc MP 2V 200S LH OFF
7manufacturers in China registered for this device type
58catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | DRS |
| Device type | Transducer, Blood-Pressure, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2850 |
| Premarket notification | Exempt |
| Record published | 2021-07-26 |
| 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 |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, case of 4, box of 20, case of 40, case of 10 |
| Sizes | Length 24 to 60 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70036001 | In distribution | ||
| 91301307 | In distribution | ||
| 80030013 | FALSE | 50 | In distribution |
| 64037107 | In distribution | ||
| 70058107 | In distribution | ||
| 70058308 | In distribution | ||
| 806010013 | FALSE | 25 | In distribution |
| 806010011 | FALSE | 25 | In distribution |
| 70030014 | Length 48 in | In distribution | |
| 80058308 | FALSE | 25 | In distribution |
| 70030051 | In distribution | ||
| 70058108 | In distribution | ||
| 80601006 | FALSE | 25 | In distribution |
| 70058307 | In distribution | ||
| 70038417 | In distribution | ||
| 70058407 | In distribution | ||
| 80058207 | FALSE | 25 | In distribution |
| 80601007 | FALSE | 25 | In distribution |
| 70058408 | In distribution | ||
| 80058208 | FALSE | 25 | In distribution |
| 64039307 | In distribution | ||
| 70038208 | In distribution | ||
| 70038217 | In distribution | ||
| 70038107 | In distribution | ||
| 70038408 | In distribution | ||
| 70038307 | In distribution | ||
| 70030020 | Length 48 in | In distribution | |
| 80601008 | FALSE | 25 | In distribution |
| 64000153 | In distribution | ||
| 70058207 | In distribution | ||
| 80038207 | FALSE | 25 | In distribution |
| 91301308 | In distribution | ||
| 70058208 | In distribution | ||
| 70038407 | In distribution | ||
| 70038207 | In distribution | ||
| 80601009 | FALSE | 25 | In distribution |
| 70030152 | In distribution | ||
| 80058307 | FALSE | 25 | In distribution |
| 70030021 | Length 48 in | In distribution | |
| 64039308 | In distribution | ||
| 70036160 | Length 60 in | In distribution | |
| 64001982 | In distribution | ||
| 70400057 | Length 48 in | In distribution | |
| 70400055 | Length 24 in | In distribution | |
| 806010010 | FALSE | 25 | In distribution |
| 70030013 | Length 24 in | In distribution | |
| 80038308 | FALSE | 25 | In distribution |
| 70038108 | In distribution | ||
| 70400052 | Length 24 in | In distribution | |
| 80038208 | FALSE | 25 | In distribution |
| 70030053 | In distribution | ||
| 806010012 | FALSE | 25 | In distribution |
| 70030054 | In distribution | ||
| 80038307 | FALSE | 25 | In distribution |
| 80400052 | FALSE | 50 | In distribution |
| 70036148 | Length 48 in | In distribution | |
| 70038308 | In distribution | ||
| 70038317 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 381 |
| Medex | ICU Medical, Inc | 225 |
| Biotrans™ Pressure Monitoring Kits | Bioptimal International Pte. Ltd. | 134 |
| Transpac™ | ICU Medical, Inc | 117 |
| Antmed | Shenzhen Antmed Co., Ltd. | 96 |
| Namic | Navilyst Medical, Inc. | 60 |
| Transpac™/Transtar™ | ICU Medical, Inc | 58 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 28 |
| Centurion | Centurion Medical Products Corporation | 23 |
| Transducer, Blood-Pressure, Extravascular | Utah Medical Products, Inc. | 22 |
| Deltran | Utah Medical Products, Inc. | 22 |
| Unimed | Unimed Medical Supplies Inc | 17 |
Showing 12 of 145. All products under Transducer, Blood-Pressure, Extravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123095 | 2013-05-08 |
| K810661 | 1981-03-27 |
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. | 6390 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. | 760 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-12 | Class II | Process change control | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. | 40 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.