|
Code
|
Display
|
Definition
|
|
128604
|
Approved for use in the clinical trial |
The protocol is approved for use in the clinical trial recorded in the protocol instance. |
|
128615
|
Ineligible for reimbursement |
The protocol is understood to be ineligible for reimbursement by a given payer. |
|
128603
|
Approved for use at the institution |
The protocol is approved for use at the institution recorded in the protocol instance. |
|
128614
|
Eligible for reimbursement on per patient basis |
The protocol is understood to be eligible for reimbursement on a per patient basis by a given payer. |
|
128617
|
Disapproved for use on pregnant patients |
The protocol is explicitly disapproved for use on pregnant patients. |
|
128606
|
Appropriate for the device |
The protocol is appropriate for execution on the device recorded in the protocol instance (which may identify an individual device by serial number or may identify a family of devices). I.e. the protocol has incorporated model-specific parameters and optimizations as necessary. |
|
128605
|
Approved for use on pregnant patients |
The protocol is specifically approved for use on pregnant patients. |
|
128619
|
Outside operational limits of the device |
The protocol specifies parameters that are not within the operational limits of the device recorded in the protocol instance. I.e. execution of the protocol may damage or exceed the operational limits of the device. |
|
128608
|
Optimized for the device instance |
The protocol is optimized for the characteristics of the specific instance of the device recorded in the protocol instance. I.e. the protocol has incorporated model-specific parameters and optimizations as necessary. |
|
128618
|
Inappropriate for the device |
The protocol is inappropriate for execution on the device recorded in the protocol instance (which may identify an individual device by serial number or may identify a family of devices). |
|
128607
|
Inside operational limits of the device |
The protocol specifies parameters that are within the operational limits of the device recorded in the protocol instance. I.e. execution of the protocol is not expected to damage or exceed the operational limits of the device. |
|
128609
|
Disapproved for any use |
The protocol is explicitly disapproved, or approval of the protocol has been withdrawn. |
|
128620
|
Not optimized for the device instance |
The protocol is not optimized for the characteristics of the specific instance of the device recorded in the protocol instance. |
|
128622
|
Inconsistent with labeling of the device |
The protocol is inconsistent with the regulatory product labeling of the device recorded in the protocol instance. |
|
128611
|
Approved for experimental use |
The protocol is approved for use in experimental procedures. |
|
128621
|
Inappropriate for the indications |
The protocol is inappropriate for the indications recorded in the protocol instance. |
|
128610
|
Deprecated protocol |
The protocol is no longer to be used. E.g. it has been replaced by another protocol. |
|
128602
|
Consistent with labeling of the device |
The protocol is consistent with the regulatory product labeling of the device recorded in the protocol instance. |
|
128624
|
Disapproved for use in the clinical trial |
The protocol is disapproved for use in the clinical trial recorded in the protocol instance. |
|
128613
|
Eligible for reimbursement |
The protocol is understood to be eligible for reimbursement by a given payer. |
|
128601
|
Appropriate for the indications |
The protocol is appropriate for the indications recorded in the protocol instance. |
|
128623
|
Disapproved for use at the institution |
The protocol is disapproved for use at the institution recorded in the approval instance. |
|
128612
|
Disapproved for experimental use |
The protocol is disapproved for use in experimental procedures. |