NeoMagic

1.9Fr x 8cm Single Lumen Polyurethane EPIV with Stylet & 27ga Sharps Safety Tearaway Sheath Introducer

Registry build 21.09.26
12manufacturers in China registered for this device type
26catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FOZ
Manufacturer City Province Registered as Device types
Amsino Medical (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 22
Bioxin Medical Co., Ltd. Weihai Shandong Contract manufacturer 8
Weihai Jierui Medical Products Co., Ltd. Weihai Shandong Contract manufacturer 3
Becton Dickinson Medical Devices Co., Ltd. Suzhou Suzhou Jiangsu Contract manufacturer 2
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Zhejiang Kindly Medical Devices Co., Ltd. Wenzhou Zhejiang Contract manufacturer 16
Terumo Medical Products (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Shandong Ande Healthcare Apparatus Co., Ltd. Zibo Shandong Manufacturer 7
Jiangxi Sanxin Medtec Co., Ltd. Nanchang Jiangxi Manufacturer 6
Haolang Technology (Foshan) Limited Corporation Foshan Guangdong Contract manufacturer 6
Guangdong Baihe Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 4
Foshan Special Medical Co., Ltd. Foshan Guangdong Manufacturer 3

Record

Regulatory record for NeoMagic
Listed by NEO Medical Inc., United States
FDA product code FOZ
Device type Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class Class 2
Regulation 21 CFR 880.5200
Establishment Specification developer, Manufacturer
510(k) K983916
Record published 2025-01-22
Record revised 2025-07-22 (version 6)

Specifications

Specifications
MRI safety MR Conditional
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
Storage Special storage condition: Keep Away From Sunlight; Special storage condition: Keep Dry
Packaging Case of 10, case of 20, case of 40, case of 50, case of 5, case of 25
Sizes Catheter gauge 1.9 to 4 Fr; length 6 to 20 cm; needle gauge 19 to 27 G; catheter length 6 to 20 cm

Catalogue Numbers

Catalogue numbers for NeoMagic
Catalogue number Size Status
2525-162 Catheter Gauge 2.5 Fr In distribution
360-300 Needle Gauge 19.0 G In distribution
1958-001 In distribution
1947-1608 Catheter Length 8 cm In distribution
1943-1606 Length 6 cm In distribution
1947-1606 Catheter Length 6 cm In distribution
1946-1606 Catheter Length 6 cm In distribution
4076-1608 Length 8.0 cm In distribution
1976-1608 Needle Gauge 27 G In distribution
1957-001 In distribution
350-300 Catheter Gauge 2.0 Fr In distribution
4043-1608 Length 8.0 cm In distribution
2096-400 Needle Gauge 27 G In distribution
3525-262 Catheter Gauge 3.5 Fr In distribution
1958-005 In distribution
1958-006 In distribution
1943-1608 Length 8 cm In distribution
1977-001 In distribution
1967-001 Catheter Gauge 1.9 Fr In distribution
1946-1608 Catheter Length 8 cm In distribution
3025-162 Catheter Gauge 3 Fr In distribution
3043-1608 Length 8.0 cm In distribution
350-25 Catheter Gauge 1.9 Fr In distribution
1976-1606 Needle Gauge 27 G In distribution
3525-162 Catheter Gauge 3.5 Fr In distribution
3076-1608 Length 8.0 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arrow Teleflex Medical LLC 2,368
Cook Cook Incorporated 250
Cook Spectrum Cook Incorporated 225
Jelco ICU Medical, Inc 104
Medline Medline Industries, Inc. 95
Deltaven Fast Flash Delta Med SpA 77
Deltaven Delta Med SpA 73
PowerGlide Pro Bard Access Systems, Inc. 63
Peripheral Catheter Insertion Kit Bard Access Systems, Inc. 62
Able Central Venous Catheter Guangdong Baihe Medical Technology Co., Ltd. 62
Curaplex Bound Tree Medical, LLC 61
BD Cathena™ Safety IV Catheter Becton, Dickinson AND Company 59

Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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