Medline Industries, Inc.
Adult Tracheostomy Supply BAG
2manufacturers in China registered for this device type
88catalogue 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 | Medline 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 | 2021-05-02 |
| Record revised | 2024-07-23 (version 7) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 3, case of 2, case of 4, case of 6, case of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJ67608A | In distribution | |
| DYNDA2896 | In distribution | |
| M106105A | In distribution | |
| M106108A | In distribution | |
| DYNDL1568 | In distribution | |
| DYNJ55523C | In distribution | |
| DYNJ33163C | In distribution | |
| DYNJ45495I | In distribution | |
| DYNDJ1129 | In distribution | |
| P727321 | In distribution | |
| DYNDJ1051 | In distribution | |
| DYNJ909743A | In distribution | |
| DYNJ61471A | In distribution | |
| DYNJ46518I | In distribution | |
| DYNJ909525B | In distribution | |
| DYNJ58574F | In distribution | |
| DYNJ85691 | In distribution | |
| DYNDA1984 | In distribution | |
| DYNDJ1024A | In distribution | |
| DYNDJ1057A | In distribution | |
| DYNDA1350 | In distribution | |
| DYNDJ1021A | In distribution | |
| CDS980376G | In distribution | |
| DYNDA1366 | In distribution | |
| DYNJ89522 | In distribution | |
| DYNJ902123I | In distribution | |
| DYNJ68208B | In distribution | |
| DYNDA2877 | In distribution | |
| DYNJ50007 | In distribution | |
| DYNJ902123J | In distribution | |
| DYNJ46518K | In distribution | |
| DYKMBNDL55 | In distribution | |
| DYNJ58574C | In distribution | |
| DYKMBNDL210 | In distribution | |
| DYNDJ1060 | In distribution | |
| DYNJ61039C | In distribution | |
| DYNJ85355 | In distribution | |
| DYKMBNDL55A | In distribution | |
| DYNDA1636 | In distribution | |
| M106121B | In distribution | |
| CDS980376F | In distribution | |
| DYND40589 | In distribution | |
| DYNDA2042 | In distribution | |
| DYNJ58574D | In distribution | |
| DYNJ902123B | In distribution | |
| DYNJ909743 | In distribution | |
| DYKM1250 | In distribution | |
| DYNDA1894 | In distribution | |
| DYNJ61039B | In distribution | |
| DYNJ44470B | In distribution | |
| DYNDA1673 | In distribution | |
| DYNJ46518G | In distribution | |
| DYNDA1931 | In distribution | |
| DYNDA1893A | In distribution | |
| DYNDJ1072 | In distribution | |
| DYNDA2546 | In distribution | |
| DYNDA2790B | In distribution | |
| DYNDA1270 | In distribution | |
| DYNJ909525A | In distribution | |
| DYKM1169 | In distribution | |
| DYNJT3293 | In distribution | |
| DYNJ64583 | In distribution | |
| DYNDJ1059 | In distribution | |
| M106211A | In distribution | |
| DYNDJ1034 | In distribution | |
| DYKM1268 | In distribution | |
| DYKM2184 | In distribution | |
| DYNDA1893 | In distribution | |
| DYNJ909525 | In distribution | |
| DYNJ50007B | In distribution | |
| DYNJAA215 | In distribution | |
| M106123A | In distribution | |
| DYNJ902123G | In distribution | |
| DYKS1504 | In distribution | |
| DYNJ84116A | In distribution | |
| DYNDA1390 | In distribution | |
| DYNDA2790A | In distribution | |
| P797716 | In distribution | |
| DYNDJ1005 | In distribution | |
| DYNJ45495G | In distribution | |
| DYNDA1488 | In distribution | |
| DYNDA1666 | In distribution | |
| DYNJ59810D | In distribution | |
| DYNJ68208A | In distribution | |
| DYNJ50007A | In distribution | |
| DYNDJ1032 | In distribution | |
| DYNDJ1030 | In distribution | |
| DYNDA2013 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| PHS | Medical Action Industries, Inc. | 1 |
| Novaplus® | Medical Action Industries, Inc. | 1 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 753 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 753 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 60 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 88 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 2683387 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 3297 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 991,744 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 28 cases (112 units) |
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.