O2-MAX
136 catalogue numbers from 313-8017XN, listed by Pulmodyne Inc., United States, under Attachment, Breathing, Positive End Expiratory Pressure. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
136catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (5), Fujian (3), elsewhere (1). 7 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 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Shenzhen Wellcore Well Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Pulmodyne Inc., United States |
|---|---|
| FDA product code | BYE |
| Device type | Attachment, Breathing, Positive End Expiratory Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5965 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-01-08 |
| Record revised | 2019-11-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 313-8017XN | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8012X-5 | 7.5cm Valve | In distribution |
| 313-8201X | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7536X | 5.0cm Valve | In distribution |
| 313-7555XN-2 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7556-5 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8005X | 15.0cm Valve | In distribution |
| 313-8007X-11 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7554X | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-8007N-6 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8108 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7533X | 5.0cm Valve | In distribution |
| 313-8018XN | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-8201-6 | In distribution | |
| 313-8007XN-5B | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7556X-2 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8017X-11 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7000-2 | In distribution | |
| 313-7557XN-1 | Adult Medium Mask | In distribution |
| 313-8017XN-13 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8008XN-1 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-8007XN-2 | Adult Medium Mask | In distribution |
| 313-7538XN-1 | Adult Medium Mask | In distribution |
| 313-8018N-6 | Adult Large Mask | In distribution |
| 313-7539-1 | Adult Large Mask | In distribution |
| 313-7457X | 5.0/7.5/12.5/15.0cm Valve | In distribution |
| 313-7534X | 7.5cm Valve | In distribution |
| 313-7070-1 | In distribution | |
| 313-7539X-1 | 10.0cm Valve | In distribution |
| 313-8007N-5 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7538XN-2 | 10.0cm Valve | In distribution |
| 313-8017XN-6 | 5.0/7.5/10.0CM Valve | In distribution |
| 313-7556XN-4 | 5.0/7.5/10.0cm valve | In distribution |
| 313-7555X-2 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7745X-9 | 5.0-7.5/10.0cm Valve | In distribution |
| 313-7070-2 | In distribution | |
| 313-7461 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7555XNF-1 | Adult Large Mask | In distribution |
| 313-7535X | 10.0cm Valve | In distribution |
| 313-8000 | In distribution | |
| 313-8017XN-5 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7555X-9 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7538X-1 | 10.0cm Valve | In distribution |
| 313-8000-5 | In distribution | |
| 313-8017X-13 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7533XN-5B | 5.0cm Valve | In distribution |
| 313-7536X-5 | 5.0cm Valve | In distribution |
| 313-8003XN | 10.0cm Valve | In distribution |
| 313-8017N-6 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7538XNF-1 | Adult Medium Mask | In distribution |
| 313-7070-3 | In distribution | |
| 313-7438X | 10.0cm Valve | In distribution |
| 313-8018-13 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7539XN | 10.0cm Valve | In distribution |
| 313-7535X-5 | 10.0cm Valve | In distribution |
| 313-7555X-1 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7070-4 | In distribution | |
| 313-7556XN-1 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7533XN-5B | 10.0cm Valve | In distribution |
| 313-7557XNF-1 | Adult Medium Mask | In distribution |
| 313-7556X-5 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8118X | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7556XN-2 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7555XN | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8007XN-6 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7555X-5 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7456X | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7557XN | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7070-7 | In distribution | |
| 313-7555X | 5.0/7.5/10.0cm | In distribution |
| 313-7538XN | 10.0cm Valve | In distribution |
| 313-8007XN | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7557XN-4 | Adult Medium Mask | In distribution |
| 313-7556XNF-1 | In distribution | |
| 313-8017N-5 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8018 | In distribution | |
| 313-7490X | 10.0cm Valve | In distribution |
| 313-8017XN-1 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8007XN-14 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8007X-13 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7533X-5 | 5.0cm Valve | In distribution |
| 313-7538X | 10.0cm Valve | In distribution |
| 313-8121-7 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7537X | 7.5cm Valve | In distribution |
| 313-8009-5 | 5.0/7.5/10.0Hcm Valve | In distribution |
| 313-7556 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7555XN-5B | Adult Large Mask | In distribution |
| 313-8007X-7 | Adult Medium Mask | In distribution |
| 313-8120 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8018N-13 | Adult Medium Mask | In distribution |
| 313-8007XNF-1 | Adult Medium Mask | In distribution |
| 313-7555XN-4 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7746X-9 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8018X-5 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7538XNF | Adult Medium Mask | In distribution |
| 313-8007XN-13 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8007XNF | Adult Medium Mask | In distribution |
| 313-7556X-1 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7755X | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7435X | 10.0cm Valve | In distribution |
| 313-8008 | 5.0/7.5/10.0/12.5/15cm Valve | In distribution |
| 313-8007N-4 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7555XN-1 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8017XN-14 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8017N-4 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8018X-5B | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7756X | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8017XN-5B | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7070 | In distribution | |
| 313-8008N-6 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7554XNF-1 | Adult Large Mask | In distribution |
| 313-7539XN-1 | 10.0cm Valve | In distribution |
| 313-7555XNF | Adult Large Mask | In distribution |
| 313-8121-11 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8202 | In distribution | |
| 313-8000-8 | In distribution | |
| 313-7554XN-4 | Adult Large Mask | In distribution |
| 313-7556X | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8200 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7557X | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-8038N-13 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-8117X-11 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8007XN-5 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7556XN | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8008X-5B | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7555-5 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-7555 | Adult Large Mask | In distribution |
| 313-7556XNF | Adult Medium Mask | In distribution |
| 313-7556X-9 | 5.0/7.5/10.0cm Valve | In distribution |
| 313-8118 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-7554XNF | Adult Large Mask | In distribution |
| 313-7554XN | Adult Large Mask | In distribution |
| 313-8001X | 5.0cm Valve | In distribution |
| 313-7070-8 | In distribution | |
| 313-7554XN-1 | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
| 313-8008XN | 5.0/7.5/10.0/12.5/15.0cm Valve | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 02-MAX | Pulmodyne Inc. | 83 |
| 02-RESQ | Pulmodyne Inc. | 43 |
| Flow-Safe II Disposable CPAP System | Mercury Medical Enterprises, LLC | 36 |
| Curaplex® | Bound Tree Medical, LLC | 31 |
| AincA | Anesthesia Associates, Inc. | 30 |
| Flow-Safe Disposable CPAP System | Mercury Medical Enterprises, LLC | 29 |
| Attachment, Breathing, Positive End Expiratory Pressure | Galemed Corp. | 25 |
| Shiley | Covidien LP | 21 |
| Infant Resuscitation Kit. T-Piece Circuit | Flexicare Medical Ltd. | 20 |
| AirLife | Carefusion | 17 |
| O2-RESQ | Pulmodyne Inc. | 17 |
| Go-PAP | Pulmodyne Inc. | 14 |
Showing 12 of 139. All products under Attachment, Breathing, Positive End Expiratory Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080256 | 2008-05-09 |
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.