Henry Schein
Tray Amnio F/ Franciscan MFM St Joes
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| 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 | 2022-04-26 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 number | Size | Per pack | Status |
|---|---|---|---|
| 5703059 | 15 | In distribution |
Same 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 |
| Amnicators | Medical Wire & Equipment Company (Bath), Ltd. | 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 |
Showing 12 of 17. All products under Sampler, Amniotic Fluid (Amniocentesis Tray)
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 510 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.