Busse Hospital Disposables
Tracheostomy Care Set, w/ Forceps, w/o gloves
2manufacturers in China registered for this device type
11catalogue 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 | Robert Busse & Co., 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 | 2016-09-02 |
| Record revised | 2026-03-18 (version 5) |
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 |
| Packaging | Pack of 20, pack of 24 |
| Distribution end date | 2026-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 703 | In distribution | |
| 799 | In distribution | |
| 710 | In distribution | |
| 714 | In distribution | |
| 715 | In distribution | |
| 711 | In distribution | |
| 714CR1 | In distribution | |
| 713 | In distribution | |
| 800 | In distribution | |
| 706 | Withdrawn | |
| 9251 | Withdrawn |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 |
| 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 |
| PHS | Medical Action Industries, Inc. | 1 |
| Novaplus® | Medical Action Industries, Inc. | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Busse Hospital Disposables | UDI-DI | 2023-11-30 | Class I | Nonconforming Material/Component | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to p | 705 |
| Busse Hospital Disposables | UDI-DI | 2023-11-30 | Class I | Nonconforming Material/Component | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to p | 240 |
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.