PHS
Catalogue number 82267, listed by Medical Action Industries, Inc., United States, under Tracheotomy Care Kit. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Medical Action Industries, Inc., United States |
|---|---|
| FDA product code | NXA |
| Device type | Tracheotomy Care Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Premarket notification | Exempt |
| Record published | 2021-10-26 |
| Record revised | 2023-05-05 (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 |
| Storage | Special storage condition: STORE AT ROOM TEMPERATURE |
| Packaging | Pack of 20 |
| Distribution end date | 2023-05-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 82267 | Withdrawn |
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 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 6 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 5 |
| Medline | Medline Industries, Inc. | 4 |
| Moore Medical | Moore Medical Corp. | 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.