Definition: Accessory Device That Secures Intravenous Administration Sets (IV Lines/tubing) To Mobile Transport Devices.
Device Type ID | 2757 |
Device Name | Administration Set Securement Device |
Physical State | Can Be Made Of Molded Plastics, Metal, Hook And Loop Tape For Attachment To Various Patient Transport Medical Devices By Means Of A Securement. Once The Accessory Device Is Secured To Patient Transfer Device, The Intravenous Administration Set (IV Li |
Technical Method | Mechanical Connects / Attaches To Medical Bed, Wheelchair Or Mobile Patient Medical Equipment. |
Target Area | Hospital Beds, Wheelchairs, Stretchers. |
Regulation Description | Intravascular Catheter Securement Device. |
Regulation Medical Specialty | General Hospital |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 880.5210 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | PUK |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2757 |
Device | Administration Set Securement Device |
Product Code | PUK |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Intravascular Catheter Securement Device. |
CFR Regulation Number | 880.5210 [🔎] |
Device Problems | |
---|---|
Migration Or Expulsion Of Device | 1 |
Total Device Problems | 1 |