Panels › Anesthesiology › Product code KGB · Class 1
Mask, Oxygen, Non-Rebreathing
Regulation 868.5570
0510(k)s in 12 months (13 all time)
0recalls in 12 months (8 all time)
6recalls that name a 510(k)
Top companies in KGB
| Company | 510(k)s | Recalls |
|---|---|---|
| Westmed, Inc. | 0 | 6 |
| Airlife, Inc. | 2 | 0 |
| Hans Rudolph, Inc. | 2 | 0 |
| Medex Inc | 0 | 2 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Cheen Houng Ent. Co. , Ltd. | 1 | 0 |
| Fittydent-Altwirth & Schmitt GmbH | 1 | 0 |
| Gam Industries, Inc. | 1 | 0 |
| Laerdal Medical Corp. | 1 | 0 |
| Medic One | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2020 | Westmed, Inc. REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to conn Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: inte Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to th Terminated |
KGB | K913164 |
| Nov 11, 2020 | Westmed, Inc. REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy Terminated |
KGB | K913164 |
| Jul 22, 2004 | Medex Inc Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84'' Tube; reorder no. 7022; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Terminated |
KGB | None listed |
| Jul 22, 2004 | Medex Inc Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle Patient Only; IPI label - Manufactured Terminated |
KGB | None listed |
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