Emergency Medical Products
IFAK Officer Down Kit w/Back Pouch
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Huan QIU LI Kang Biotech Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Emergency Medical Products, Inc. |
|---|---|
| FDA product code | LMG |
| Device type | Agent, Absorbable Hemostatic, Non-Collagen Based |
| Device class | Class 3 |
| Regulation | 21 CFR 878.4490 |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2022-06-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DR-1 | In distribution | |
| IFAK2-B | In distribution | |
| EMPX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgicel | Ethicon Sàrl | 8 |
| Surgicel NU-Knit | Ethicon Sàrl | 6 |
| Surgicel SNoW | Ethicon, Inc. | 6 |
| Arista | Davol Inc. | 6 |
| Surgicel Fibrillar | Ethicon, Inc. | 5 |
| PerClot | Baxter Healthcare Corporation | 5 |
| Veriset | Covidien LP | 3 |
| Surgicel Fibrillar | Ethicon Sàrl | 3 |
| Surgicel | Ethicon, Inc. | 1 |
| Tabotamp Fibrillar | Ethicon, Inc. | 1 |
| Ethicon | Ethicon, Inc. | 1 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P210036 | 2023-05-19 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation |
| N12159 | 2023-04-04 | SURGICEL® Absorbable Hemostats (SURGICEL® POWDER) | Ethicon, Inc. |
| P050038 | 2012-03-23 | ARISTA AH ABSORBABLE HEMOSTAT | Davol Inc. |
| N5798 | 1991-02-08 | OXYCELL | Bd Becton Dickinson Vacutainer Systems Preanalytic |
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.