Quik Fil
Quik Fil Adapter for use with sevoflurane
1manufacturer
1catalogue number
5510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Southmedic, Inc., Canada |
|---|---|
| FDA product code | CAD |
| Device type | Vaporizer, Anesthesia, Non-Heated |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5880 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K945993 |
| Record published | 2018-02-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M40000 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 107 |
| Penlon | Penlon Ltd. | 11 |
| TEC 7 | Datex-Ohmeda, Inc. | 10 |
| Antispil | Southmedic, Inc. | 5 |
| Vapofil™ | Southmedic, Inc. | 5 |
| TEC | Datex-Ohmeda, Inc. | 4 |
| TEC 6 Plus | Datex-Ohmeda, Inc. | 3 |
| AincA® | Anesthesia Associates, Inc. | 1 |
| Flexible arm assembly FRU | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| V80 Anesthetic Vaporizer | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Sevoflurane Key Filler Vaporizer(FDA) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Key Filler Bottle Adaptor MRI | Penlon Ltd. | 1 |
Showing 12 of 20. All products under Vaporizer, Anesthesia, Non-Heated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K945993 | 1995-02-22 |
| K923265 | 1993-03-18 |
| K861839 | 1986-05-21 |
| K860545 | 1986-04-17 |
| K843993 | 1984-11-15 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Southmedic, Inc. | 510(k) number | 2006-04-21 | Not classified | Other | Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia an | 69 in US (211 Worldwide) | 2012-03-06 |
| Southmedic, Inc. | 510(k) number | 2006-04-21 | Not classified | Other | Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia an | 186 in US (403 Worldwide) | 2012-03-06 |
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.