Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
| Device Type ID | 108 |
| Device Name | Arterial Blood Sampling Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Regulation Description | Arterial Blood Sampling Kit. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 868.1100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CBT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 108 |
| Device | Arterial Blood Sampling Kit |
| Product Code | CBT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Arterial Blood Sampling Kit. |
| CFR Regulation Number | 868.1100 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 14 |
Tube | 6 |
Display Or Visual Feedback Problem | 4 |
Disconnection | 3 |
Leak / Splash | 3 |
Excess Flow Or Over-Infusion | 2 |
Break | 2 |
Device Operates Differently Than Expected | 2 |
Failure To Advance | 1 |
High Readings | 1 |
Appropriate Term/Code Not Available | 1 |
Pressure Tubing | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Detachment Of Device Or Device Component | 1 |
Loose Or Intermittent Connection | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Transducer | 1 |
| Total Device Problems | 45 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cardinal Health | II | Sep-02-2016 |
| 2 | Vyaire Medical | II | Aug-28-2017 |