7450 RV2 Mask
7450 X-Small Face Mask With Inlet Valves
72manufacturers in China registered for this device type
136catalogue numbers in this listing
2510(k) clearances naming this product 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 | Hans Rudolph, Inc., United States |
|---|---|
| FDA product code | KGB |
| Device type | Mask, Oxygen, Non-Rebreathing |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5570 |
| Establishment | Manufacturer |
| Record published | 2023-04-05 |
| Record revised | 2024-10-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-10-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
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Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 8960 Mask | Hans Rudolph, Inc. | 8 |
Showing 12 of 139. All products under Mask, Oxygen, Non-Rebreathing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960401 | 1996-06-20 |
| K933583 | 1994-01-03 |
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.