Namic

NAMIC Perceptor Compensator Medium Pressure 2 Valve Manifold, Off Handles, Ports on Right

Registry build 21.09.26
7manufacturers in China registered for this device type
60catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code DRS
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

Regulatory record for Namic
Listed by Navilyst Medical, Inc., United States
FDA product code DRS
Device type Transducer, Blood-Pressure, Extravascular
Device class Class 2
Regulation 21 CFR 870.2850
510(k) K910764
Record published 2016-09-20
Record revised 2018-07-06 (version 4)

Specifications

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 10, box of 25, box of 50
Sizes Length 24 to 60 in

Catalogue Numbers

Catalogue numbers for Namic
Catalogue number Size Status
70030014 Length 48 in In distribution
64039307 Length 48 in In distribution
80030013 In distribution
70038317 In distribution
70058108 In distribution
70038217 In distribution
70038308 In distribution
70036160 Length 60 in In distribution
70038108 In distribution
80058208 In distribution
70058307 In distribution
70058208 In distribution
70058308 In distribution
70038417 In distribution
70400055 Length 24 in In distribution
70400057 Length 48 in In distribution
70038407 In distribution
70400052 Length 24 in In distribution
70030020 Length 48 in In distribution
70030054 In distribution
70030053 In distribution
806010012 In distribution
70030013 Length 24 in In distribution
80601007 In distribution
80038307 In distribution
70058417 In distribution
70038307 In distribution
80058308 In distribution
80038308 In distribution
64000153 In distribution
80601009 In distribution
806010013 In distribution
70038408 In distribution
70030051 In distribution
64037107 Length 48 in In distribution
64039308 Length 48 in In distribution
80058307 In distribution
80601008 In distribution
70038107 In distribution
80038207 In distribution
70058407 In distribution
80601006 In distribution
70058317 In distribution
70058107 In distribution
80038208 In distribution
64001982 In distribution
70038207 In distribution
806010010 In distribution
70030152 In distribution
64000352 In distribution
70058408 In distribution
80030052 In distribution
70036001 In distribution
70036148 Length 48 in In distribution
70030021 Length 48 in In distribution
806010011 In distribution
70058217 In distribution
80058207 In distribution
70038208 In distribution
70058207 In distribution

Same Product Code

Other products under the same FDA 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 Medline Industries, Inc. 58
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

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Namic
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
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. 6390 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. 760 units
Medline Industries, LP – Northfield 510(k) number 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer