Dale PediPrints
Dale PediPrints Tracheostomy Tube Holder, .75" wide, fits up to 9" neck.
46manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (12), Guangdong (9). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Xiantao Rayxin Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 18 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
Showing 12 of 46. All 46 manufacturers in China registered for Device, Fixation, Tracheal Tube
Record
| Listed by | Dale Medical Products, Inc., United States |
|---|---|
| FDA product code | CBH |
| Device type | Device, Fixation, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5770 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-27 |
| Record revised | 2024-04-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 241 | In distribution | |
| 241 | In distribution | |
| 242 | In distribution | |
| 242 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZCare™ Softouch | Neotech Products, LLC | 31 |
| Marpac Inc | Marpac, Inc. | 29 |
| Trach Tie | Pepper Medical, Inc. | 27 |
| Tracoe care | Tracoe Medical Gmbh | 15 |
| Dr Zee | Resp Devices LLC | 14 |
| NeoBar® | Neotech Products, LLC | 14 |
| Bioseal Inc. | Bioseal | 14 |
| ProCure | Twin Med, LLC | 13 |
| Hudson RCI | Teleflex Medical LLC | 11 |
| Vent Tie | Pepper Medical, Inc. | 10 |
| Medline | Medline Industries, Inc. | 9 |
| Posey | Posey Products, LLC | 8 |
Showing 12 of 123. All products under Device, Fixation, Tracheal Tube
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K964399 | 1997-01-28 |
| K951491 | 1995-04-24 |
| K905231 | 1991-01-14 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-03-24 | Class II | Nonconforming Material/Component | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient’s face. | 34,770 total | 2018-05-21 |
| 2017-03-24 | Class II | Nonconforming Material/Component | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient’s face. | 34,770 total | 2018-05-21 |
| 2007-09-27 | Not classified | Labeling design | Revised Labeling : Instructions For use: “Do not trim fastener hook tabs. ” Trimming can cause tabs to disengage at the trach plate | 65,000 | 2012-05-09 |
| 2007-09-27 | Not classified | Labeling design | Revised Labeling : Instructions For use: “Do not trim fastener hook tabs. ” Trimming can cause tabs to disengage at the trach plate | 600,000 units | 2012-05-09 |
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.