Non-Rebreather Mask
Mask, Pediatric, Non-Rebreather w/Safety Vent and 7' KROT, and Threaded nut connector
72manufacturers in China registered for this device type
3catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Zhejiang (25), Guangdong (14), Jiangsu (13). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen | Jiangsu | Contract manufacturer | 14 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 72. All 72 manufacturers in China registered for Mask, Oxygen, Non-Rebreathing
Record
| Listed by | Westmed, Inc., United States |
|---|---|
| FDA product code | KGB |
| Device type | Mask, Oxygen, Non-Rebreathing |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5570 |
| Establishment | Contract manufacturer, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-30 |
| Record revised | 2023-05-01 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 50 |
| Distribution end date | 2025-12-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0366 | Withdrawn | |
| 0367 | Withdrawn | |
| 0365 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 7450 RV2 Mask | Hans Rudolph, Inc. | 136 |
| 6450 RV2 Mask | Hans Rudolph, Inc. | 23 |
| Hudson RCI | Teleflex Medical LLC | 22 |
| Mask, Oxygen, Non-Rebreathing | Salter Labs | 17 |
| 7400 RV2 Mask | Hans Rudolph, Inc. | 16 |
| Venticaire Lite | Flexicare Medical Ltd. | 14 |
| Curaplex | Bound Tree Medical, LLC | 12 |
| 7930 Mask | Hans Rudolph, Inc. | 10 |
| 8950 Mask | Hans Rudolph, Inc. | 10 |
| MedSource Non-Rebreather Mask | Medsource International, LLC | 10 |
| 7940 Mask | Hans Rudolph, Inc. | 9 |
| Resp-O2 O2 Non-Rebreather Elongated Mask | Dynarex Corp. | 8 |
Showing 12 of 139. All products under Mask, Oxygen, Non-Rebreathing
Recalls
6 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 |
|---|---|---|---|---|---|
| 2020-11-11 | Class II | Process control | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatme | 37,300 units | 2023-02-07 |
| 2020-11-11 | Class II | Process control | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatme | 3000 units | 2023-02-07 |
| 2020-11-11 | Class II | Process control | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatme | 16,000 units | 2023-02-07 |
| 2020-11-11 | Class II | Process control | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatme | 1200 units | 2023-02-07 |
| 2020-11-11 | Class II | Process control | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatme | 600 units | 2023-02-07 |
| 2020-11-11 | Class II | Process control | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatme | 6000 units | 2023-02-07 |
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.