Cardinal Health
Sterile Anesthesia Tracheotomy
2manufacturers in China registered for this device type
46catalogue 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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | NXA |
| Device type | Tracheotomy Care Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-06 |
| Record revised | 2020-10-21 (version 4) |
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, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 20, case of 50, case of 10, case of 2, case of 36, case of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEN4ETRAL1 | In distribution | |
| 15-0798H | In distribution | |
| BN11-0007A | In distribution | |
| 15-6759E | In distribution | |
| 15-4609A | In distribution | |
| BN11-0007 | In distribution | |
| 15A0114A | In distribution | |
| 15-0145A | In distribution | |
| 15-0585B | In distribution | |
| 15-0114A | In distribution | |
| 15-7896A | In distribution | |
| 15-7896C | In distribution | |
| 11-1100CA | In distribution | |
| 15-5431A | In distribution | |
| SEN4ETRALB | In distribution | |
| 15-2758A | In distribution | |
| 15-0114C | In distribution | |
| SEN11TTWHG | In distribution | |
| 15-7896D | In distribution | |
| 11-5431D | In distribution | |
| 15-0798D | In distribution | |
| 15-7896 | In distribution | |
| 11-5431C | In distribution | |
| 15-0798C | In distribution | |
| 15-1360A | In distribution | |
| 15A0114D | In distribution | |
| 15-7896B | In distribution | |
| 15-8920 | In distribution | |
| 24-6608A | In distribution | |
| 15-0798B | In distribution | |
| 15-6759C | In distribution | |
| 15-8920D | In distribution | |
| 15-0798G | In distribution | |
| 11-1100 | In distribution | |
| SEN4ETRALA | In distribution | |
| 15A0114B | In distribution | |
| 15-0798E | In distribution | |
| 15-8920B | In distribution | |
| 24-7896A | In distribution | |
| 15-0114B | In distribution | |
| 15-6759D | In distribution | |
| 15-0585A | In distribution | |
| 15-8920A | In distribution | |
| 15A0114C | In distribution | |
| 15-0798A | In distribution | |
| 15-8920C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 88 |
| 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 |
| 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.