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 | 180 |
| Device Name | Blood Specimen Collection Kit (excludes Hiv Testing) |
| 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 868.1100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OFZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 180 |
| Device | Blood Specimen Collection Kit (excludes Hiv Testing) |
| Product Code | OFZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Arterial Blood Sampling Kit. |
| CFR Regulation Number | 868.1100 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Plunger | 1 |
Fluid Leak | 1 |
Incorrect Or Inadequate Test Results | 1 |
Device Operates Differently Than Expected | 1 |
Syringe | 1 |
| Total Device Problems | 7 |