Amnicators

Amnicator - For the Detection of PROM

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code HIO
Manufacturer City Province Registered as Device types
Changzhou Meiguan Care Products Technology Co., Ltd. Changzhou Jiangsu Manufacturer 32

Record

Regulatory record for Amnicators
Listed by Medical Wire & Equipment Company (Bath), Ltd., United Kingdom
FDA product code HIO
Device type Sampler, Amniotic Fluid (Amniocentesis Tray)
Device class Class 1
Regulation 21 CFR 884.1550
Premarket notification Exempt
Record published 2023-10-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 5 to 25 °C

Catalogue Numbers

Catalogue numbers for Amnicators
Catalogue number Size Per pack Status
N/a 20 In distribution
N/a 50 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 82
Echotip Cook Incorporated 23
Aligned Medical Solutions Aligned Medical Solutions 9
Amniocentesis Tray Argon Medical Devices, Inc. 3
Stradis Healthcare Stradis Healthcare 2
Amniocentesis Needle Vitrolife Sweden AB 2
Busse Hospital Disposables Robert Busse & Co., Inc. 2
AmnioTest (Nitrazine yellow swab) pro-lab incorporated 1
Sampler, Amniotic Fluid (Amniocentesis Tray) Carefusion 2200, Inc. 1
Stradis Stradis Healthcare 1
AmnioTest (Nitrazine yellow swab 100 box) pro-lab incorporated 1
DeRoyal Deroyal Industries, Inc. 1

Showing 12 of 17. All products under Sampler, Amniotic Fluid (Amniocentesis Tray)

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