One-Step™

167 catalogue numbers from 00884450298879, listed by Merit Medical Systems, Inc., United States, under Catheter, Irrigation. 24 manufacturers in China are registered for this product code.

Registry build 21.09.26
24manufacturers in China registered for this device type
167catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (7), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GBX
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Zhejiang Baite Medical Appliances Co., Ltd. Huzhou Zhejiang Contract manufacturer 13
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Lidesen Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 100
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65

Showing 12 of 24. All 24 manufacturers in China registered for Catheter, Irrigation

Record

Regulatory record for One-Step™
Listed by Merit Medical Systems, Inc., United States
FDA product code GBX
Device type Catheter, Irrigation
Device class Class 1
Regulation 21 CFR 878.4200
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2019-07-11
Record revised 2025-03-28 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Packaging Pack of 5, pack of 22, pack of 4

Catalogue Numbers

Catalogue numbers for One-Step™
Catalogue number Size Status
00884450298879 Catheter Tip Configuration-Straight In distribution
00884450023785 Catheter Tip Configuration-Straight In distribution
00884450536605 Catheter Length (cm)-17 cm In distribution
00884450092583 Catheter French Size (F)-4F In distribution
00884450536483 Catheter French Size (F)-6F In distribution
00884450298794 Catheter French Size (F)-6F In distribution
00884450387016 Catheter French Size (F)-6F In distribution
00884450298831 Catheter French Size (F)-6F In distribution
00884450288559 Catheter French Size (F)-8F In distribution
00884450298626 Catheter Tip Configuration-Pigtail In distribution
00884450288474 Catheter Length (cm)-7 cm In distribution
00884450536391 Catheter French Size (F)-6F In distribution
00884450536421 Catheter French Size (F)-5F In distribution
00884450298558 Catheter Length (cm)-7 cm In distribution
00884450298572 Catheter Length (cm)-7 cm In distribution
00884450537336 Catheter French Size (F)-8F In distribution
00884450085912 Catheter Tip Configuration-Straight In distribution
00884450298763 Catheter French Size (F)-6F In distribution
00884450536292 Catheter Tip Configuration-Pigtail In distribution
C Catheter Length (cm)-12 cm In distribution
00884450298428 Catheter French Size (F)-5F In distribution
00884450298671 Catheter Tip Configuration-Pigtail In distribution
00884450012031 Catheter Tip Configuration-Straight In distribution
00884450536612 Catheter French Size (F)-8F In distribution
00884450298633 Catheter French Size (F)-8F In distribution
00884450030011 Catheter Length (cm)-15 cm In distribution
00884450329993 Catheter French Size (F)-6F In distribution
00884450386989 Catheter French Size (F)-6F In distribution
00884450536650 Catheter Tip Configuration-Straight In distribution
00884450386767 Catheter French Size (F)-4F In distribution
00884450032909 Catheter Length (cm)-15 cm In distribution
00884450536544 Catheter French Size (F)-6F In distribution
00884450386972 Catheter Tip Configuration-Pigtail In distribution
00884450537381 Catheter French Size (F)-8F In distribution
00884450386880 Catheter Length (cm)-12 cm In distribution
00884450050637 Catheter Length (cm)-7 cm In distribution
00884450298862 Catheter Length (cm)-10 cm In distribution
00884450298893 Catheter French Size (F)-8F In distribution
00884450387580 Catheter French Size (F)-8F In distribution
00884450330029 Catheter Tip Configuration-Straight In distribution
00884450298527 Catheter Tip Configuration-Straight In distribution
00884450298503 Catheter Length (cm)-15 cm In distribution
00884450298756 Catheter Tip Configuration-Straight In distribution
00884450386941 Catheter Tip Configuration-Pigtail In distribution
00884450536629 Catheter French Size (F)-8F In distribution
00884450386903 Catheter Length (cm)-12 cm In distribution
00884450092507 Catheter Length (cm)-10 cm In distribution
00884450288511 Catheter Length (cm)-12 cm In distribution
00884450012079 Catheter Tip Configuration-Straight In distribution
00884450032886 Catheter French Size (F)-5F In distribution
00884450536735 Catheter Tip Configuration-Straight In distribution
00884450387023 Catheter French Size (F)-6F In distribution
00884450387610 Catheter Length (cm)-17 cm In distribution
00884450536780 Catheter French Size (F)-8F In distribution
00884450298923 Catheter French Size (F)-8F In distribution
00884450092491 Catheter Length (cm)-10 cm In distribution
00884450288535 Catheter French Size (F)-8F In distribution
00884450092736 In distribution
00884450329986 Catheter French Size (F)-6F In distribution
00884450032954 Catheter Tip Configuration-Straight In distribution
00884450012062 Catheter Tip Configuration-Straight In distribution
00884450298541 Catheter Tip Configuration-Pigtail In distribution
00884450536339 Catheter Tip Configuration-Pigtail In distribution
00884450536469 Catheter French Size (F)-5F In distribution
00884450288375 Catheter Length (cm)-12 cm In distribution
00884450536520 Catheter French Size (F)-6F In distribution
00884450536513 Catheter French Size (F)-6F In distribution
00884450298848 Catheter Length (cm)-10 cm In distribution
00884450012048 Catheter Length (cm)-10 cm In distribution
00884450032893 Catheter Length (cm)-10 cm In distribution
00884450537107 Catheter French Size (F)-8F In distribution
00884450092712 Catheter Tip Configuration-Straight In distribution
00884450330005 Catheter Length (cm)-10 cm In distribution
00884450387078 Catheter French Size (F)-8F In distribution
00884450092606 Catheter French Size (F)-5F In distribution
00884450536414 Catheter French Size (F)-6F In distribution
00884450244333 In distribution
00884450032978 Catheter Tip Configuration-Straight In distribution
00884450298855 Catheter French Size (F)-8F In distribution
00884450092620 In distribution
00884450387030 Catheter French Size (F)-6F In distribution
00884450536353 Catheter French Size (F)-4F In distribution
00884450536445 Catheter French Size (F)-5F In distribution
00884450298916 Catheter French Size (F)-8F In distribution
00884450536568 Catheter Tip Configuration-Straight In distribution
00884450536360 Catheter Tip Configuration-Pigtail In distribution
00884450298695 Catheter French Size (F)-8F In distribution
00884450298824 Catheter Tip Configuration-Straight In distribution
00884450298657 Catheter Length (cm)-15 cm In distribution
00884450330012 Catheter French Size (F)-8F In distribution
00884450387054 Catheter French Size (F)-6F In distribution
00884450536537 Catheter French Size (F)-6F In distribution
00884450085868 Catheter Tip Configuration-Straight In distribution
00884450386910 Catheter Length (cm)-12 cm In distribution
00884450387061 Catheter French Size (F)-8F In distribution
00884450288498 Catheter French Size (F)-8F In distribution
00884450298909 Catheter French Size (F)-8F In distribution
00884450298497 Catheter French Size (F)-6F In distribution
C Catheter Length (cm)-15 cm In distribution
00884450536681 Catheter French Size (F)-8F In distribution
00884450288290 Catheter Tip Configuration-Pigtail In distribution
00884450092538 Catheter Length (cm)-10 cm In distribution
00884450536667 Catheter French Size (F)-8F In distribution
00884450298565 Catheter Length (cm)-7 cm In distribution
00884450536551 Catheter French Size (F)-6F In distribution
00884450536728 Catheter Length (cm)-7 cm In distribution
00884450387009 Catheter Length (cm)-12 cm In distribution
00884450298510 Catheter French Size (F)-6F In distribution
00884450092552 Catheter Length (cm)-7 cm In distribution
00884450537305 Catheter Length (cm)-17 cm In distribution
00884450536582 Catheter French Size (F)-6F In distribution
00884450387597 Catheter French Size (F)-8F In distribution
00884450032879 Catheter Tip Configuration-Straight In distribution
00884450298770 Catheter Tip Configuration-Straight In distribution
00884450536476 Catheter French Size (F)-6F In distribution
00884450032947 Catheter Tip Configuration-Straight In distribution
00884450298701 Catheter French Size (F)-8F In distribution
00884450288610 Catheter French Size (F)-8F In distribution
00884450288313 Catheter Tip Configuration-Pigtail In distribution
00884450536407 Catheter French Size (F)-5F In distribution
00884450386965 Catheter Tip Configuration-Pigtail In distribution
00884450092705 Catheter French Size (F)-5F In distribution
00884450386927 Catheter Tip Configuration-Pigtail In distribution
00884450032992 Catheter French Size (F)-5F In distribution
00884450536452 Catheter French Size (F)-6F In distribution
00884450536599 Catheter French Size (F)-6F In distribution
00884450288450 Catheter French Size (F)-6F In distribution
00884450288399 Catheter Tip Configuration-Pigtail In distribution
C Catheter Length (cm)-12 cm In distribution
00884450092644 Catheter French Size (F)-5F In distribution
00884450025994 Catheter Length (cm)-7 cm In distribution
00884450298473 Catheter Tip Configuration-Straight In distribution
00884450386958 Catheter French Size (F)-5F In distribution
C Catheter Tip Configuration-Pigtail In distribution
00884450092750 Catheter Tip Configuration-Straight In distribution
00884450537343 Catheter French Size (F)-8F In distribution
00884450298459 Catheter Tip Configuration-Straight In distribution
00884450288412 Catheter Length (cm)-15 cm In distribution
00884450387641 Catheter Length (cm)-17 cm In distribution
00884450536254 Catheter Tip Configuration-Pigtail In distribution
00884450288351 Catheter Tip Configuration-Straight In distribution
C Catheter French Size (F)-8F In distribution
00884450288337 Catheter Tip Configuration-Pigtail In distribution
00884450538999 Catheter French Size (F)-8F In distribution
00884450537312 Catheter Tip Configuration-Straight In distribution
00884450288276 Catheter Length (cm)-12 cm In distribution
00884450537282 Catheter French Size (F)-8F In distribution
00884450298787 In distribution
00884450536636 Catheter French Size (F)-6F In distribution
00884450298602 Catheter Length (cm)-10 cm In distribution
00884450298800 Catheter French Size (F)-6F In distribution
00884450092682 Catheter Length (cm)-15 cm In distribution
00884450012055 Catheter French Size (F)-5F In distribution
00884450092668 Catheter French Size (F)-5F In distribution
00884450288597 Catheter Length (cm)-17 cm In distribution
00884450298817 Catheter Length (cm)-7 cm In distribution
00884450298442 Catheter Length (cm)-17 cm In distribution
00884450288573 Catheter Length (cm)-17 cm In distribution
00884450536704 Catheter French Size (F)-8F In distribution
00884450298466 Catheter Length (cm)-10 cm In distribution
00884450288436 Catheter Length (cm)-17 cm In distribution
00884450536506 Catheter French Size (F)-6F In distribution
00884450298589 Catheter French Size (F)-8F In distribution
00884450298688 Catheter Tip Configuration-Straight In distribution
00884450386897 Catheter Tip Configuration-Pigtail In distribution
00884450536643 Catheter French Size (F)-8F In distribution
00884450536438 Catheter French Size (F)-6F In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 109
Cook Cook Incorporated 85
ReSolve® Merit Medical Systems, Inc. 68
Pleur-Evac Teleflex Medical LLC 66
Jackson-Pratt Cardinal Health 200, LLC 47
Total Abscession AngioDynamics, Inc. 36
Channel Drain C.R. Bard, Inc. 36
ReSolve Mini™ Merit Medical Systems, Inc. 32
Silicone Tubing, Radiopaque Bentec Medical OpCo, LLC. 25
Blake Ethicon, Inc. 19
Silicone Tubing, Translucent Bentec Medical OpCo, LLC. 19
Thoracentesis and Paracentesis Set Merit Medical Systems, Inc. 17

Showing 12 of 223. All products under Catheter, Irrigation

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