Trinity Sterile, Inc.
Trach Care SET W/Forceps
2manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
Record
| Listed by | Trinity Sterile, Inc., United States |
|---|---|
| FDA product code | NXA |
| Device type | Tracheotomy Care Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-30 |
| Record revised | 2023-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20129 | In distribution | |
| 20104 | In distribution | |
| 20120 | In distribution | |
| 20128 | In distribution | |
| 20107 | In distribution | |
| 20103 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 88 |
| Cardinal Health | Cardinal Health 200, LLC | 46 |
| Medical Action Industries | Medical Action Industries, Inc. | 21 |
| MedStream | Medical Specialties Distributors, Inc. | 14 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 11 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 5 |
| Medline | Medline Industries, Inc. | 4 |
| Moore Medical | Moore Medical Corp. | 1 |
| PHS | Medical Action Industries, Inc. | 1 |
| Novaplus® | Medical Action Industries, Inc. | 1 |
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.