Who else makes this device?

Name: HydroMID Maximal Barrier Kit
Brand: HydroMID Maximal Barrier Kit

HydroMID Maximal Barrier Kit · Catheter, Intravascular, Therapeutic, Short-Term Less than 30 Days → General Hospital

12manufacturers in China registered for this device type

3catalogue numbers in this listing

3510(k) clearances naming this product code

5recalls on this code

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 HydroMID Maximal Barrier Kit
Listed by	Access Vascular, 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	Manufacturer
510(k)	K220772
Record published	2023-11-30
Record revised	2024-02-08 (version 3)

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

Catalogue Numbers

Catalogue numbers for HydroMID Maximal Barrier Kit
Catalogue number	Size	Status
80H04104		In distribution
80004004		In distribution
80004104		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K244059	2025-03-27
K220772	2022-12-07
K203069	2021-02-08

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 HydroMID Maximal Barrier Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Access Vascular, Inc	510(k) number	2022-12-22	Class II	Under Investigation by firm	Product Mislabeled on the outer bag and inner kit Tyvek header bag	155 units
Access Vascular, Inc	510(k) number	2022-12-22	Class II	Under Investigation by firm	Label with the incorrect component listed on the inner kit Tyvek header bag	445 units
Access Vascular, Inc	510(k) number	2022-12-16	Class II	Incorrect or no expiration date	Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.	1,789 HydroMID devices

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2022-12-16	Class II	Incorrect or no expiration date	Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.	302 HydroPICC devices
2022-12-16	Class II	Incorrect or no expiration date	Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

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.

HydroMID Maximal Barrier Kit