Medline
TRAY,TRACH,14FR Suction Cath,whistle TIP
3manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OGV |
| Device type | Tracheostomy Cleaning Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Premarket notification | Exempt |
| Record published | 2021-09-23 |
| Record revised | 2020-10-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Avoid excessive heat. Protect from freezing. |
| Packaging | Pack of 20, pack of 30, pack of 10, pack of 3, case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNDJ1055 | In distribution | |
| CC3T3030A | In distribution | |
| CC3T4691A | In distribution | |
| DYNDJ1050 | In distribution | |
| DYNDJ1035 | In distribution | |
| DYNDJ1053 | In distribution | |
| DYNDX40582 | In distribution | |
| DYNDN1010 | In distribution | |
| DYNDJ1062 | In distribution | |
| DYND40610 | In distribution | |
| CC4681A | In distribution | |
| DYND40511 | In distribution | |
| DYNDJ1047 | In distribution | |
| DYNDJ1056 | In distribution | |
| DYNDT1013 | In distribution | |
| DYNDJ1069 | In distribution | |
| DYNDJ1038 | In distribution | |
| DYND40610VA | In distribution | |
| DYK1023785E | In distribution | |
| DYND40582 | In distribution | |
| CC4682A | In distribution | |
| DYND40622 | In distribution | |
| DYND40580 | In distribution | |
| DYND40620 | In distribution | |
| DYND40582VA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AirLife | Carefusion | 6 |
| Cardinal Health | Cardinal Health 200, LLC | 6 |
| Tracoe care | Tracoe Medical Gmbh | 2 |
| Professional Medical Surgical Supply, Inc. d / b / a International Direct | Professional Medical-Surgical Supply, Incorporated | 2 |
| Medical Equipment Affiliates | Medline 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 |
|---|---|---|---|---|---|---|
| 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 | 385028 trays |
| Medline Industries, LP – Northfield | UDI-DI | 2023-10-16 | Class I | Under Investigation by firm | The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the | 620,735 kits |
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.