Mask, Oxygen
Pediatric Oxygen Mask High Concentration Non-rebreather. With Thread grip connector. 7 ft. tubing. Elastic strap style. Under the chin fit. Vinyl.
126manufacturers in China registered for this device type
61catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (40), Guangdong (29), Jiangsu (23). 24 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 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
Showing 12 of 126. All 126 manufacturers in China registered for Mask, Oxygen
Record
| Listed by | Salter Labs, United States |
|---|---|
| FDA product code | BYG |
| Device type | Mask, Oxygen |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5580 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-11-30 |
| Record revised | 2026-03-27 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment temperature -40 to 60 °C; Special storage condition: N/A |
| Packaging | Pack of 50, pack of 10, pack of 30, pack of 25 |
| Distribution end date | 2026-03-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8100TLC-0 | Adult | In distribution |
| SO-1510-0 | Pediatric | In distribution |
| M125335-0 | Adult | In distribution |
| L8110-7-50 | Adult | In distribution |
| 1100-0 | Adult | In distribution |
| 8100-0 | Adult | In distribution |
| M3210-0 | adult | In distribution |
| 1078 | In distribution | |
| SO-429-0 | In distribution | |
| 1077-0 | In distribution | |
| 1123 | Adult | In distribution |
| 8125-0 | Adult | In distribution |
| M125469-0 | Adult | In distribution |
| 1111 | Adult | In distribution |
| 1005255 | Pediatric | In distribution |
| M000795 | In distribution | |
| SO-307-0 | Adult | In distribution |
| M124996 | Pediatric | In distribution |
| 1122-7 | Pediatric | In distribution |
| 8110TLC-7 | Adult | In distribution |
| M838142-0 | In distribution | |
| 1102-7 | Adult | In distribution |
| 8020-7 | Adult | In distribution |
| 1108 | Pediatric | In distribution |
| M000797 | In distribution | |
| 1115 | Infant | In distribution |
| 1114-7 | Infant | In distribution |
| 8110-7 | Adult | In distribution |
| 1103 | Adult | In distribution |
| SO-1216-0 | Pediatric | In distribution |
| 8107 | Adult | In distribution |
| SO-407-0 | Adult | In distribution |
| M811374-0 | adult | In distribution |
| 1113 | Infant | In distribution |
| 1120-5 | Pediatric | In distribution |
| 1046 | Adult | In distribution |
| 1107-0 | Pediatric | In distribution |
| SO-65-0 | Adult | In distribution |
| 1111TLC | Adult | In distribution |
| SO-1174-0 | Pediatric | In distribution |
| 8110TG-7 | Adult | In distribution |
| 1140-7 | Pediatric | In distribution |
| 1130-7 | Pediatric | In distribution |
| 1110-0 | Adult | In distribution |
| 8010-0 | Adult | In distribution |
| 1130TG-7 | Pediatric | In distribution |
| 1110TLC | Adult | In distribution |
| SO-297-0 | Pediatric | Withdrawn |
| 1050-7 | Adult | Withdrawn |
| 8000 | Adult | Withdrawn |
| 8005-7 | Adult | Withdrawn |
| SO-98-0 | Adult | Withdrawn |
| 1120 | Pediatric | Withdrawn |
| SO-428-0 | Adult | Withdrawn |
| 8115 | Adult | Withdrawn |
| SO-295-0 | Adult | Withdrawn |
| SO-318-0 | Adult | Withdrawn |
| SO-294-0 | Adult | Withdrawn |
| 1127-7 | Pediatric | Withdrawn |
| 1112-6 | Adult | Withdrawn |
| 1122TG-7 | Pediatric | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 87 |
| Curaplex | TRI-Anim Health Services, Inc. | 34 |
| 7301 EAGLE1 | Hans Rudolph, Inc. | 33 |
| Curaplex | Bound Tree Medical, LLC | 33 |
| Roscoe | Drive DeVilbiss Healthcare | 32 |
| BF | Allied Medical LLC | 28 |
| Ventlab | Ventlab, LLC | 25 |
| Adsafe™ | American Diagnostic Corp. | 25 |
| 7302 EAGLE2 | Hans Rudolph, Inc. | 24 |
| Oxygen Mask | Well Lead Medical Co., Ltd. | 24 |
| AirLife™ | Airlife, Inc. | 21 |
| Procure | Twin Med, LLC | 19 |
Showing 12 of 302. All products under Mask, Oxygen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K912633 | 1991-07-19 |
| K865047 | 1987-02-10 |
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.