Microstream Advance
Adult-Intermediate Bite Block CO2 Filter Line with O2 Tubing;Short-term use: Procedural/Emergency
29manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (17), Jiangsu (5), Zhejiang (3). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 29. All 29 manufacturers in China registered for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | CCK |
| Device type | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1400 |
| 510(k) | K181467 |
| Record published | 2023-01-14 |
| Record revised | 2026-01-26 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -4 to 131 °F |
| Packaging | Case of 25 |
| Sizes | Length 2 to 4 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZMVABOL | Length 4 m | In distribution |
| ZMVAO | Length 2 m | In distribution |
| ZMVANOH | Airflow Volume, less than or equal to 5, Liter/min; | In distribution |
| ZMVAI | Length 2 m | In distribution |
| ZMVAIH | Length 2 m | In distribution |
| ZMVAIHH | Length 2 m | In distribution |
| ZMVABO | Length 2 m | In distribution |
| ZMVAOL | Airflow Volume, less than or equal to 5, Liter/min; | In distribution |
| ZMVPO | Airflow Volume, less than or equal to 5, Liter/min; | In distribution |
| ZMVAOH | Length 2 m | In distribution |
| ZMVIIH | Length 2 m | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Salter Labs | 241 |
| Microstream | Oridion Medical 1987 Ltd. | 92 |
| Hudson RCI | Teleflex Medical LLC | 79 |
| Medline | Medline Industries, Inc. | 65 |
| BCI | ICU Medical, Inc | 64 |
| Curaplex | Bound Tree Medical, LLC | 60 |
| Microstream Advance | Oridion Medical 1987 Ltd. | 51 |
| Ventlab | Ventlab, LLC | 42 |
| Vital Signs | Carefusion Finland 320 Oy | 33 |
| AirLife™ | Airlife, Inc. | 32 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Nihon Kohden Corp. | 23 |
| Curaplex | TRI-Anim Health Services, Inc. | 23 |
Showing 12 of 441. All products under Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Recalls Naming This Product
11 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 |
|---|---|---|---|---|---|---|
| Philips North America LLC | 510(k) number | 2025-04-07 | Class II | Unknown/Undetermined by firm | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. | 486,631 units |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 318292 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 5125183 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 31175 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 7076 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 11850 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 3800 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 350 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 62877 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 8435772 |
| Oridion Medical 1987 Ltd. | 510(k) number | 2025-02-17 | Class II | Labeling design | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. s | 704423 |
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.